PRA Health Sciences - Early Development Serices
Groningen, Netherlands
NCT Number: NCT03478020
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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Notify Me18 year–45 year
Female
Interventional
Phase 1
Groningen, Netherlands
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Investigational Drug
COC containing 100 ug Levonorgestrel (LNG) and 20 ug Ethinyl Estradiol (EE)
Time frame: 8 Weeks (from start of treatment period A to completion of treatment period B)
To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC
Time frame: 8 Weeks (from start of treatment period A to completion of treatment period B)
To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC
Time frame: 8 Weeks (from start of treatment period A to completion of treatment period B)
To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC
Time frame: 8 Weeks (from start of treatment period A to completion of treatment period B)
To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC
Time frame: 8 Weeks (from start of treatment period A to completion of treatment period B)
To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC
Time frame: 16 weeks (from start of pre-treatment cycle 1 to completion of treatment period B)
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
Time frame: 8 Weeks (from start of treatment period A to completion of treatment period B)
To assess the PK of 200 mg AQX-1125 qd when given together with the COC
Time frame: 8 Weeks (from start of treatment period A to completion of treatment period B)
To assess the PK of 200 mg AQX-1125 qd when given together with the COC
Time frame: 8 Weeks (from start of treatment period A to completion of treatment period B)
To assess the PK of 200 mg AQX-1125 qd when given together with the COC
Time frame: 8 Weeks (from start of treatment period A to completion of treatment period B)
To assess the PK of 200 mg AQX-1125 qd when given together with the COC
Time frame: 8 Weeks (from start of treatment period A to completion of treatment period B)
To assess the PK of 200 mg AQX-1125 qd when given together with the COC
Aquinox Pharmaceuticals (Canada) Inc.
Industry
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
Acronym: DDI-COC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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