Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-02-25 @ 7:51 PM
Study NCT ID:
NCT03478020
Status:
COMPLETED
Last Update Posted:
2018-06-13
First Post:
2018-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral AQX-1125 and Combination Oral Contraceptive Drug-Drug Interaction Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C582990', 'term': '4-(4-(aminomethyl)-7a-methyl-1-methylideneoctahydro-1H-inden-5-yl)-3-(hydroxymethyl)-4-methylcyclohexan-1-ol'}, {'id': 'D003277', 'term': 'Contraceptives, Oral, Combined'}], 'ancestors': [{'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D003276', 'term': 'Contraceptives, Oral'}, {'id': 'D003271', 'term': 'Contraceptive Agents, Female'}, {'id': 'D003270', 'term': 'Contraceptive Agents'}, {'id': 'D012102', 'term': 'Reproductive Control Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-12', 'studyFirstSubmitDate': '2018-03-19', 'studyFirstSubmitQcDate': '2018-03-23', 'lastUpdatePostDateStruct': {'date': '2018-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax) of COC taken with AQX-1125', 'timeFrame': '8 Weeks (from start of treatment period A to completion of treatment period B)', 'description': 'To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC'}, {'measure': 'Time to attain maximum observed plasma concentration (tmax) of COC taken with AQX-1125', 'timeFrame': '8 Weeks (from start of treatment period A to completion of treatment period B)', 'description': 'To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC'}, {'measure': 'Area under the plasma concentration-time curve up to 24 hours (AUC0-24) of COC taken with AQX-1125', 'timeFrame': '8 Weeks (from start of treatment period A to completion of treatment period B)', 'description': 'To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC'}, {'measure': 'Terminal elimination rate constant (Kel) of COC taken with AQX-1125', 'timeFrame': '8 Weeks (from start of treatment period A to completion of treatment period B)', 'description': 'To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC'}, {'measure': 'Terminal elimination half-life (t1/2) of COC taken with AQX-1125', 'timeFrame': '8 Weeks (from start of treatment period A to completion of treatment period B)', 'description': 'To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability of AQX-1125 200 mg qd administered with the COC', 'timeFrame': '16 weeks (from start of pre-treatment cycle 1 to completion of treatment period B)', 'description': 'Safety and tolerability will be assessed by the severity and frequency of adverse events, which will include any abnormal clinically significant vital signs, laboratory tests, electrocardiogram and physical examination findings'}, {'measure': 'Maximum observed plasma concentration (Cmax) of AQX-1125 taken with COC', 'timeFrame': '8 Weeks (from start of treatment period A to completion of treatment period B)', 'description': 'To assess the PK of 200 mg AQX-1125 qd when given together with the COC'}, {'measure': 'Time to attain maximum observed plasma concentration (tmax) of AQX-1125 taken with COC', 'timeFrame': '8 Weeks (from start of treatment period A to completion of treatment period B)', 'description': 'To assess the PK of 200 mg AQX-1125 qd when given together with the COC'}, {'measure': 'Area under the plasma concentration-time curve up to 24 hours (AUC0-24) of AQX-1125 taken with COC', 'timeFrame': '8 Weeks (from start of treatment period A to completion of treatment period B)', 'description': 'To assess the PK of 200 mg AQX-1125 qd when given together with the COC'}, {'measure': 'Terminal elimination rate constant (Kel) of AQX-1125 taken with COC', 'timeFrame': '8 Weeks (from start of treatment period A to completion of treatment period B)', 'description': 'To assess the PK of 200 mg AQX-1125 qd when given together with the COC'}, {'measure': 'Terminal elimination half-life (t1/2) of AQX-1125 taken with COC', 'timeFrame': '8 Weeks (from start of treatment period A to completion of treatment period B)', 'description': 'To assess the PK of 200 mg AQX-1125 qd when given together with the COC'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'This is an open-label, fixed sequence, 4 cycle, drug-drug interaction (DDI) study of AQX-1125 in healthy female subjects on combination oral contraceptives (COC).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Pre-Menopausal Female Subjects', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-45 years, inclusive, at time of signing Informed Consent\n* Adult females of child bearing potential, who are non-pregnant and non-lactating, and must agree to use adequate additional contraception from the start of Treatment Period A until 90 days after the last dose of AQX-1125\n* BMI 18.0 - 35.0 kg/m2\n* Good physical and mental health based on medical history, physical examination, clinical laboratory, ECG and vital signs, as judged by the investigator\n\nExclusion Criteria:\n\n* Previous participation in the current study\n* Any clinically significant history of breakthrough bleeding\n* Using tobacco or other nicotine containing products within 12 months prior to the first study-specific COC-cycle intake\n* History of alcohol abuse or drug addiction\n* Positive drug and alcohol screen at screening and (each) admission to the clinical research center\n* Average intake of more than 24 units of alcohol per week\n* Positive screen for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies or anti-human immunodeficiency virus (HIV) 1 and 2 antibodies\n* Participation in a drug study within 30 days prior to screening. Participation in more than 2 other drug studies in the 10 months prior to (the first) drug administration in the current study\n* Donation or loss of more than 100 mL of blood within 60 days prior to the start of Treatment Period A, on Day 1. Donation or loss of more than 1.0 liters of blood in the 10 months prior to the start of Treatment Period A, on Day 1\n* Significant and/or acute illness within 5 days prior to Day 1 in Treatment Period A, that may impact safety assessments, in the opinion of the investigator\n* Unsuitable veins for blood sampling'}, 'identificationModule': {'nctId': 'NCT03478020', 'acronym': 'DDI-COC', 'briefTitle': 'Oral AQX-1125 and Combination Oral Contraceptive Drug-Drug Interaction Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aquinox Pharmaceuticals (Canada) Inc.'}, 'officialTitle': 'Open-Label, Fixed-Sequence 3-Period Study to Determine the Effects of Repeated Oral Dosing of AQX-1125 on the Pharamacokinetics, Safety and Tolerability of a Combination Oral Contraceptive in Healthy Female Subjects', 'orgStudyIdInfo': {'id': 'AQX-1125-104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pre-Treatment, Treatment Cycles A & B', 'description': 'Pre-Treatment: Two cycles of a combined oral contraceptive (COC) taken orally once daily for 21 days followed by 7 COC-free days.\n\nTreatment Period A: COC containing taken orally once daily for 21 days followed by 7 COC-free days.\n\nTreatment Period B: COC taken orally once daily for 21 days, with once daily oral 200 mg AQX-1125 (2 x 100 mg tablets) co-administered from Day 13 to 21, followed by 7 COC-free days', 'interventionNames': ['Drug: AQX-1125', 'Drug: Combined Oral Contraceptive']}], 'interventions': [{'name': 'AQX-1125', 'type': 'DRUG', 'description': 'Investigational Drug', 'armGroupLabels': ['Pre-Treatment, Treatment Cycles A & B']}, {'name': 'Combined Oral Contraceptive', 'type': 'DRUG', 'description': 'COC containing 100 ug Levonorgestrel (LNG) and 20 ug Ethinyl Estradiol (EE)', 'armGroupLabels': ['Pre-Treatment, Treatment Cycles A & B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Groningen', 'country': 'Netherlands', 'facility': 'PRA Health Sciences - Early Development Serices', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'Jeroen van de Wetering, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PRA Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aquinox Pharmaceuticals (Canada) Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}