Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT05070702
Status:
COMPLETED
Last Update Posted:
2022-07-15
First Post:
2021-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
First in Human Study of CT-1500 in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Active and Placebo capsules are identical in appearance.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Ascending Single Doses followed by Ascending Multiple Doses of Study Intervention'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-13', 'studyFirstSubmitDate': '2021-09-13', 'studyFirstSubmitQcDate': '2021-09-27', 'lastUpdatePostDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events (AEs) and Serious Adverse Events (SAEs) during the SAD part of the study', 'timeFrame': 'Initiation of dosing through 7 days post dose', 'description': 'Incidence and severity of AEs and SAEs'}, {'measure': 'Adverse Events and Serious Adverse Events during the MAD part of the study', 'timeFrame': 'Initiation of dosing through 14 days post dose', 'description': 'Incidence and severity of AEs and SAEs'}, {'measure': 'Tolerability of CT-1500 as defined by change from baseline in Heart Rate (SAD)', 'timeFrame': 'Initiation of dosing through 7 days post dose'}, {'measure': 'Tolerability of CT-1500 as defined by change from baseline in Heart Rate (MAD)', 'timeFrame': 'Initiation of dosing through 14 days post dose'}, {'measure': 'Tolerability of CT-1500 as defined by change from baseline in Respiratory Rate (SAD)', 'timeFrame': 'Initiation of dosing through 7 days post dose'}, {'measure': 'Tolerability of CT-1500 as defined by change from baseline in Respiratory Rate (MAD)', 'timeFrame': 'Initiation of dosing through 14 days post dose'}, {'measure': 'Tolerability of CT-1500 as defined by change from baseline in Electrocardiogram Assessment (SAD)', 'timeFrame': 'Initiation of dosing through 7 days post dose', 'description': 'Change in QT interval from baseline'}, {'measure': 'Tolerability of CT-1500 as defined by change from baseline in Electrocardiogram assessment (MAD)', 'timeFrame': 'Initiation of dosing through 14 days post dose', 'description': 'Change in QT interval from baseline'}, {'measure': 'Tolerability of CT-1500 as defined by change from baseline in Spirometry assessment (SAD)', 'timeFrame': 'Initiation of dosing through 7 days post dose', 'description': 'Change from baseline in Forced Expiratory Volume in 1 second (FEV1)'}, {'measure': 'Tolerability of CT-1500 as defined by change from baseline in Spirometry assessment (MAD)', 'timeFrame': 'Initiation of dosing through 14 days post dose', 'description': 'Change from baseline in Forced Expiratory Volume in 1 second (FEV1)'}, {'measure': 'Change in Renal function from baseline (SAD)', 'timeFrame': 'Initiation of dosing through 24 hours post dose', 'description': 'Renal Function as assessed by change in estimated Glomerular Filtration Rate from baseline'}, {'measure': 'Change in Renal function from baseline (MAD)', 'timeFrame': 'Initiation of dosing on Day 1 through 24 hours and initiation of dosing on Day 7 through 24 hours', 'description': 'Renal Function as assessed by change in estimated Glomerular Filtration Rate from baseline'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic parameter: AUC-last (SAD)', 'timeFrame': 'Baseline (predose) through 48 hours post dose', 'description': 'Area under the plasma concentration time curve (AUC) from time zero until the last measurable concentration of CT-1500 is observed during the SAD part of the study'}, {'measure': 'Pharmacokinetic parameter: AUC-last (SAD)', 'timeFrame': 'Baseline (predose) through 48 hours post dose', 'description': 'Area under the plasma concentration time curve from time zero until the last measurable concentration of metabolite CT-1517 is observed during the SAD part of the study'}, {'measure': 'Pharmacokinetic parameter: AUC-last (SAD)', 'timeFrame': 'Baseline (predose) through 48 hours post dose', 'description': 'Area under the plasma concentration time curve from time zero until the last measurable concentration of metabolite CT-1518 is observed during the SAD part of the study'}, {'measure': 'Pharmacokinetic parameter: AUC-last (MAD)', 'timeFrame': 'Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours', 'description': 'Area under the plasma concentration time curve from time zero until the last measurable concentration of CT-1500 is observed during the MAD part of the study'}, {'measure': 'Pharmacokinetic parameter: AUC-last (MAD)', 'timeFrame': 'Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours', 'description': 'Area under the plasma concentration time curve from time zero until the last measurable concentration of metabolite CT-1517 is observed during the MAD part of the study'}, {'measure': 'Pharmacokinetic parameter: AUC-last (MAD)', 'timeFrame': 'Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours', 'description': 'Area under the plasma concentration time curve from time zero until the last measurable concentration of metabolite CT-1518 is observed during the MAD part of the study'}, {'measure': 'Pharmacokinetic parameter: AUC-inf (SAD)', 'timeFrame': 'Baseline (predose) through 48 hours post dose', 'description': 'Area under the plasma concentration time curve from time zero to infinity of CT-1500 is observed during the SAD part of the study'}, {'measure': 'Pharmacokinetic parameter: AUC-inf (MAD)', 'timeFrame': 'Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours', 'description': 'Area under the plasma concentration time curve from time zero to infinity of CT-1500 is observed during the MAD part of the study'}, {'measure': 'Pharmacokinetic parameter: Cmax (SAD)', 'timeFrame': 'Baseline (predose) through 48 hours post dose', 'description': 'Maximal measured plasma concentration (Cmax) of CT-1500 during the SAD part of the study'}, {'measure': 'Pharmacokinetic parameter: Cmax (SAD)', 'timeFrame': 'Baseline (predose) through 48 hours post dose', 'description': 'Maximal measured plasma concentration of metabolite CT-1517 during the SAD part of the study'}, {'measure': 'Pharmacokinetic parameter: Cmax (SAD)', 'timeFrame': 'Baseline (predose) through 48 hours post dose', 'description': 'Maximal measured plasma concentration of metabolite CT-1518 during the SAD part of the study'}, {'measure': 'Pharmacokinetic parameter: Cmax (MAD)', 'timeFrame': 'Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours', 'description': 'Maximal measured plasma concentration of CT-1500 during the MAD part of the study'}, {'measure': 'Pharmacokinetic parameter: Cmax (MAD)', 'timeFrame': 'Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours', 'description': 'Maximal measured plasma concentration of metabolite CT-1517 during the MAD part of the study'}, {'measure': 'Pharmacokinetic parameter: Cmax (MAD)', 'timeFrame': 'Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours', 'description': 'Maximal measured plasma concentration of metabolite CT-1518 during the MAD part of the study'}, {'measure': 'Pharmacokinetic parameter: Tmax (SAD)', 'timeFrame': 'Baseline (predose) through 48 hours post dose', 'description': 'Time when Maximal measured plasma concentration is observed (Tmax) of CT-1500 during the SAD part of the study'}, {'measure': 'Pharmacokinetic parameter: Tmax (SAD)', 'timeFrame': 'Baseline (predose) through 48 hours post dose', 'description': 'Time when Maximal measured plasma concentration is observed of metabolite CT-1517 during the SAD part of the study'}, {'measure': 'Pharmacokinetic parameter: Tmax (SAD)', 'timeFrame': 'Baseline (predose) through 48 hours post dose', 'description': 'Time when Maximal measured plasma concentration is observed of metabolite CT-1518 during the SAD part of the study'}, {'measure': 'Pharmacokinetic parameter: Tmax (MAD)', 'timeFrame': 'Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours', 'description': 'Time when Maximal measured plasma concentration is observed of CT-1500 during the MAD part of the study'}, {'measure': 'Pharmacokinetic parameter: Tmax (MAD)', 'timeFrame': 'Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours', 'description': 'Time when Maximal measured plasma concentration is observed of metabolite CT-1517 during the MAD part of the study'}, {'measure': 'Pharmacokinetic parameter: Tmax (MAD)', 'timeFrame': 'Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours', 'description': 'Time when Maximal measured plasma concentration is observed of metabolite CT-1518 during the MAD part of the study'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study is a single center, randomized, placebo-controlled, double-blind study of CT-1500 in healthy volunteers. The study will evaluate the safety, tolerability and pharmacokinetics of single ascending doses and multiple ascending doses of orally administered CT-1500 compared to placebo.', 'detailedDescription': 'This study is a single center, randomized, placebo-controlled, double-blind study of CT-1500 in healthy volunteers. The study will evaluate the safety, tolerability and pharmacokinetics of single ascending doses and multiple ascending doses of orally administered CT-1500 compared to placebo. It is planned for 5 dose levels to be investigated in the single ascending dose (SAD) part (Part 1) of the study, between 5 mg to 120 mg. Three dose levels are proposed for investigation in the multiple ascending dose (MAD) part (Part 2) of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Generally healthy with the exception of those medical conditions allowed per the study criteria\n* Able to provide voluntary, written informed consent with comprehension of all aspects of the protocol, prior to any study procedures\n* Body Mass Index (BMI) of 18.5 to 32 kg/m2 and weight \\>48 kg\n* Systolic Blood Pressure (BP) of 90-140 mmHg, Diastolic BP of 40-90 mmHg and Heart Rate between 40 and 100 bpm\n* Forced Expiratory Volume in one second (FEV1) \\> 85% predicted\n* Clinical laboratory results at screening and Day -1 to be within normal limits unless deemed as not clinically significant by the investigator\n* Willing to consume bovine containing products (investigational product capsules are bovine gelatin in origin);\n* Agree not to donate blood or plasma products for at least 30 days after the end of study (EOS) visit\n* Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at Day -1, must not be breastfeeding, lactating or planning a pregnancy and must use an acceptable form of contraception during the treatment period and for 32 days after the last dose\n* Male participants with a female partner of childbearing potential must agree to use an acceptable form of contraception during the treatment period and for 92 days after the last dose\n\nExclusion Criteria:\n\n* Significant current or historical disease, including intercurrent illness in the 4 weeks prior to screening\n* Current or historical diagnosis of sleep disorders\n* Hepatic disorders other than benign unconjugated hyperbilirubinaemia\n* History of moderate or severe psychiatric illness\n* History of severe allergy or anaphylaxis to any drug, food, toxin or other exposure\n* Heavy caffeine drinker in the last 3 months. If subjects are willing to reduce their caffeine intake for 14 days prior to first dose and for the duration of the study, they can participate\n* Hypersensitivity to CT-1500 or any of the inert excipients in the capsule formulation\n* Positive hepatitis B surface antigen (HBsAg), positive hepatitis C antibody (HCV) or positive human immunodeficiency virus (HIV) test\n* Treatment with an investigational drug within 30 days or less than 5 half-lives (whichever is longer) prior to screening\n* Use of prescription medication within 14 days prior to investigational product administration until the end of study visit, with the exception of oral contraceptives.\n* Use of over-the-counter medication and supplements for 7 days prior to investigation product administration until the end of study visit. Exceptions at the discretion of the investigator.\n* Receipt of a Coronavirus disease 2019 (COVID-19) vaccine within 14 days prior to investigational product administration or a planned second dose of a COVID-19 vaccine during study participation\n* Use of tobacco or nicotine-containing products in excess of 2 cigarettes per day within 1 month prior to screening\n* Major surgery in the 6 months preceeding screening or planned surgery during the study\n* Donated blood or blood products or had a substantial loss of blood with 3 months prior to screening\n* A history of drug abuse or addiction\n* A history of alcoholism or consumption of more than 3 alcoholic drinks per day or consumption of alcohol within 48 hours prior to first dose\n* Unable to abstain from grapefruit-containing foods or beverages or Seville orange-containing foods or beverages from 48 hours prior to investigational product administration until completion of the confinement period;\n* Unable to avoid heavy exercise (eg, marathon runners, weight-lifters) from 48 hours prior to investigational product administration until completion of the confinement period'}, 'identificationModule': {'nctId': 'NCT05070702', 'briefTitle': 'First in Human Study of CT-1500 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Circadian Therapeutics Ltd'}, 'officialTitle': 'First in Human Study in Healthy Subjects to Investigate the Safety, Tolerability and Pharmacokinetics of Single Ascending and Repeat Doses of CT-1500', 'orgStudyIdInfo': {'id': 'CT-1500-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CT-1500 Active (SAD)', 'description': '6 out of 8 participants per cohort (up to 5 cohorts) will be randomized to receive a single oral dose of CT-1500 between 5 mg and 120 mg', 'interventionNames': ['Drug: CT-1500']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (SAD)', 'description': '2 out of 8 participants per cohort (up to 5 cohorts) will be randomized to receive a single oral dose of matching placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'CT-1500 Active (MAD)', 'description': '6 out of 8 participants per cohort (up to 3 cohorts) will be randomized to receive 7 daily oral doses of CT-1500 between 5 and 45 mg', 'interventionNames': ['Drug: CT-1500']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (MAD)', 'description': '2 out of 8 participants per cohort (up to 3 cohorts) will be randomized to receive 7 daily oral doses of matching placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'CT-1500', 'type': 'DRUG', 'description': 'Hard Capsule', 'armGroupLabels': ['CT-1500 Active (MAD)', 'CT-1500 Active (SAD)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Hard Capsule', 'armGroupLabels': ['Placebo (MAD)', 'Placebo (SAD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Nucleus Network', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Philip Ryan, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nucleus Network'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'ipdSharing': 'YES', 'description': 'The Sponsor will consider requests from appropriately qualified researchers for study information and participant data upon a formal request to contact@circadiantherapeutics.com.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Circadian Therapeutics Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Neuroscience Trials Australia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}