Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2025-12-29 @ 2:35 AM
Study NCT ID:
NCT03527095
Status:
COMPLETED
Last Update Posted:
2018-11-02
First Post:
2018-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Compare the Pharmacokinetics of Different Oral Formulations of FDL169 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-01', 'studyFirstSubmitDate': '2018-05-04', 'studyFirstSubmitQcDate': '2018-05-15', 'lastUpdatePostDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative bioavailability of FDL169 and its metabolites with different formulations', 'timeFrame': '17 weeks', 'description': 'To determine the relative bioavailability of FDL169 and its metabolites M1 and M3, following different tablet formulations compared to a reference tablet'}], 'secondaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': '17 weeks', 'description': 'Safety and tolerability of FDL169 and its metabolites M1 and M3 , as determined by the incidence of adverse events (Aes) and serious adverse events (SAE)s.'}, {'measure': 'Pharmacokinetic parameters, Cmax', 'timeFrame': '17 weeks', 'description': 'The pharmacokinetic parameters of FDL169 and its metabolites M1 and M3 , maximal plasma concentration (Cmax)'}, {'measure': 'Pharmacokinetic parameters, Tmax', 'timeFrame': '17 weeks', 'description': 'The pharmacokinetic parameters of FDL169 and its metabolites M1 and M3; maximal concentration (Tmax)'}, {'measure': 'Pharmacokinetic parameters, AUC', 'timeFrame': '17 weeks', 'description': 'The pharmacokinetic parameters of FDL169 and its metabolites M1 and M3; area under the plasma concentration curve (AUC)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cystic Fibrosis'], 'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'This is a randomised, cross-over study comprised of 6 periods in healthy subjects.Subjects will receive Regimens A, B and C in a randomised crossover manner in the fed state, followed by Regimens D, E and F in a randomised crossover manner, in the fasted or fed state, as applicable.', 'detailedDescription': 'This is a single centre, randomised, cross-over study comprised of 6 periods in healthy males and females.Subjects will receive Regimens A, B and C in a randomised crossover manner in the fed state, followed by Regimens D, E and F in a randomised crossover manner, in the fasted or fed state, as applicable.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and non-pregnant, non-lactating female subjects\n* Aged 18 to 55 years\n* Body mass index of 18.0 to 32.0 kg/m2\n* Must agree to the use of an adequate method of contraception\n\nExclusion Criteria:\n\n* Subjects who have received any IMP in a clinical research study within the previous 3 months\n* History of any drug or alcohol abuse in the past 2 years\n* Current smokers and those who have smoked within the last 12 months.\n* Alkaline phosphatase, aspartate aminotransferase and/or alanine aminotransferase level \\>1.5 x upper limit of normal at screening\n* Abnormal renal function at screening\n* Clinically significant abnormal biochemistry, haematology, coagulation profile or urinalysis\n* Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results\n* History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or GI disease, neurological or psychiatric disorder.\n* Subjects with a history of gall stones or abdominal surgery eg cholecystectomy\n* Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients\n* Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedy (including known inhibitors or inducers of CYP3A4'}, 'identificationModule': {'nctId': 'NCT03527095', 'briefTitle': 'A Study to Compare the Pharmacokinetics of Different Oral Formulations of FDL169 in Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Flatley Discovery Lab LLC'}, 'officialTitle': 'A Phase 1, Open-label, Randomised, Cross Over Study to Compare the Pharmacokinetics of Different Oral Formulations of FDL169 in Healthy Subjects Following Single Doses', 'orgStudyIdInfo': {'id': 'FDL169-2017-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Regimen A', 'description': 'FDL169 200 mg reference tablet', 'interventionNames': ['Drug: FDL169']}, {'type': 'EXPERIMENTAL', 'label': 'Regimen B', 'description': 'FDL169 200 mg testing tablet 1', 'interventionNames': ['Drug: FDL169']}, {'type': 'EXPERIMENTAL', 'label': 'Regimen C', 'description': 'FDL169 200 mg testing tablet 2', 'interventionNames': ['Drug: FDL169']}, {'type': 'EXPERIMENTAL', 'label': 'Regimen D', 'description': 'FDL169 200 mg testing tablet 1 or 2 with high fat diet', 'interventionNames': ['Drug: FDL169']}, {'type': 'EXPERIMENTAL', 'label': 'Regimen E', 'description': 'FDL169 200 mg testing tablet 1 or 2, fasted', 'interventionNames': ['Drug: FDL169']}, {'type': 'EXPERIMENTAL', 'label': 'Regimen F', 'description': 'FDL169 200 mg testing tablet 1 or 2, with standard diet', 'interventionNames': ['Drug: FDL169']}], 'interventions': [{'name': 'FDL169', 'type': 'DRUG', 'description': 'CFTR corrector', 'armGroupLabels': ['Regimen A', 'Regimen B', 'Regimen C', 'Regimen D', 'Regimen E', 'Regimen F']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG11 6JS', 'city': 'Ruddington', 'state': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Quotient Sciences', 'geoPoint': {'lat': 52.89254, 'lon': -1.14953}}], 'overallOfficials': [{'name': 'Claudia Ordonez', 'role': 'STUDY_CHAIR', 'affiliation': 'Flatley Discovery Lab'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Flatley Discovery Lab LLC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}