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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-Treatment, Treatment Cycles A & B | Experimental | Pre-Treatment: Two cycles of a combined oral contraceptive (COC) taken orally once daily for 21 days followed by 7 COC-free days. Treatment Period A: COC containing taken orally once daily for 21 days followed by 7 COC-free days. Treatment 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AQX-1125 | Drug | Investigational Drug |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of COC taken with AQX-1125 | To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC | 8 Weeks (from start of treatment period A to completion of treatment period B) |
| Time to attain maximum observed plasma concentration (tmax) of COC taken with AQX-1125 | To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC | 8 Weeks (from start of treatment period A to completion of treatment period B) |
| Area under the plasma concentration-time curve up to 24 hours (AUC0-24) of COC taken with AQX-1125 | To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC | 8 Weeks (from start of treatment period A to completion of treatment period B) |
| Terminal elimination rate constant (Kel) of COC taken with AQX-1125 | To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC | 8 Weeks (from start of treatment period A to completion of treatment period B) |
| Terminal elimination half-life (t1/2) of COC taken with AQX-1125 | To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC | 8 Weeks (from start of treatment period A to completion of treatment period B) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of AQX-1125 200 mg qd administered with the COC | 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 | 16 weeks (from start of pre-treatment cycle 1 to completion of treatment period B) |
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Inclusion Criteria:
Exclusion Criteria:
Pre-Menopausal Female Subjects
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| Name | Affiliation | Role |
|---|---|---|
| Jeroen van de Wetering, MD | PRA Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Health Sciences - Early Development Serices | Groningen | Netherlands |
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| ID | Term |
|---|---|
| C582990 | 4-(4-(aminomethyl)-7a-methyl-1-methylideneoctahydro-1H-inden-5-yl)-3-(hydroxymethyl)-4-methylcyclohexan-1-ol |
| D003277 | Contraceptives, Oral, Combined |
| ID | Term |
|---|---|
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D003276 | Contraceptives, Oral |
| D003271 | Contraceptive Agents, Female |
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| Combined Oral Contraceptive |
| Drug |
COC containing 100 ug Levonorgestrel (LNG) and 20 ug Ethinyl Estradiol (EE) |
|
| Maximum observed plasma concentration (Cmax) of AQX-1125 taken with COC | To assess the PK of 200 mg AQX-1125 qd when given together with the COC | 8 Weeks (from start of treatment period A to completion of treatment period B) |
| Time to attain maximum observed plasma concentration (tmax) of AQX-1125 taken with COC | To assess the PK of 200 mg AQX-1125 qd when given together with the COC | 8 Weeks (from start of treatment period A to completion of treatment period B) |
| Area under the plasma concentration-time curve up to 24 hours (AUC0-24) of AQX-1125 taken with COC | To assess the PK of 200 mg AQX-1125 qd when given together with the COC | 8 Weeks (from start of treatment period A to completion of treatment period B) |
| Terminal elimination rate constant (Kel) of AQX-1125 taken with COC | To assess the PK of 200 mg AQX-1125 qd when given together with the COC | 8 Weeks (from start of treatment period A to completion of treatment period B) |
| Terminal elimination half-life (t1/2) of AQX-1125 taken with COC | To assess the PK of 200 mg AQX-1125 qd when given together with the COC | 8 Weeks (from start of treatment period A to completion of treatment period B) |
| D003270 | Contraceptive Agents |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |