Healthy VolunteerPhase 1DDI-COCNCT03478020
Oral AQX-1125 and Combination Oral Contraceptive Drug-Drug Interaction Study
A Phase 1 study testing AQX-1125 and Combined Oral Contraceptive in people with Healthy Volunteer, run by Aquinox Pharmaceuticals (Canada) Inc. at 1 site in Netherlands.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- AQX-1125 and Combined Oral Contraceptive
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Nov 2017to 5 Apr 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-45 years, inclusive, at time of signing Informed Consent
- 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
- BMI 18.0 - 35.0 kg/m2
- Good physical and mental health based on medical history, physical examination, clinical laboratory, ECG and vital signs, as judged by the investigator
Who cannot join
- Previous participation in the current study
- Any clinically significant history of breakthrough bleeding
- Using tobacco or other nicotine containing products within 12 months prior to the first study-specific COC-cycle intake
- History of alcohol abuse or drug addiction
- Positive drug and alcohol screen at screening and (each) admission to the clinical research center
- Average intake of more than 24 units of alcohol per week
Show all 11Show fewer
- Positive screen for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies or anti-human immunodeficiency virus (HIV) 1 and 2 antibodies
- 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
- 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
- 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
- Unsuitable veins for blood sampling
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
PRA Health Sciences - Early Development Serices
Groningen
About this study
Official title: 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
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).
- Conditions
- Healthy Volunteer
- Being tested
- AQX-1125, Combined Oral Contraceptive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AQX-1125Drug
Investigational Drug
Combined Oral ContraceptiveDrug
COC containing 100 ug Levonorgestrel (LNG) and 20 ug Ethinyl Estradiol (EE)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: AQX-1125; Drug: Combined Oral Contraceptive |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 8 Weeks (from start of treatment period A to completion of treatment period B)
Secondary outcomes (6)
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
Measured: 16 weeks (from start of pre-treatment cycle 1 to completion of treatment period B)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 8 Weeks (from start of treatment period A to completion of treatment period B)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start22 Nov 2017
- Primary completion29 Mar 2018
- Study completion5 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aquinox Pharmaceuticals (Canada) Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeroen van de Wetering, MD, Principal investigator, PRA Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478020
- Sponsor's protocol ID
- AQX-1125-104
- Acronym
- DDI-COC
- Status last verified
- Jun 2018
- First submitted
- 19 Mar 2018
- Last updated
- 13 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03478020
- Acronym / sponsor ID
- DDI-COC / AQX-1125-104
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Aquinox Pharmaceuticals (Canada) Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Nov 2017 (actual)
- Primary completion
- 29 Mar 2018 (actual)
- Study completion
- 5 Apr 2018 (actual)
- First posted
- 27 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-Treatment, Treatment Cycles A & B | Experimental | Drug: AQX-1125, Drug: Combined Oral ContraceptivePre-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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 18-45 years, inclusive, at time of signing Informed Consent
- 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
- BMI 18.0 - 35.0 kg/m2
- Good physical and mental health based on medical history, physical examination, clinical laboratory, ECG and vital signs, as judged by the investigator
Key exclusion criteria (11 listed)
- Previous participation in the current study
- Any clinically significant history of breakthrough bleeding
- Using tobacco or other nicotine containing products within 12 months prior to the first study-specific COC-cycle intake
- History of alcohol abuse or drug addiction
- Positive drug and alcohol screen at screening and (each) admission to the clinical research center
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AQX-1125Investigational Drug | Drug | Pre-Treatment, Treatment Cycles A & B |
| Combined Oral ContraceptiveCOC containing 100 ug Levonorgestrel (LNG) and 20 ug Ethinyl Estradiol (EE) | Drug | Pre-Treatment, Treatment Cycles A & B |
Primary outcome
Maximum observed plasma concentration (Cmax) of COC taken with AQX-1125
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 to attain maximum observed plasma concentration (tmax) of COC taken with AQX-1125
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
Area under the plasma concentration-time curve up to 24 hours (AUC0-24) of COC taken with AQX-1125
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
Terminal elimination rate constant (Kel) of COC taken with AQX-1125
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
Terminal elimination half-life (t1/2) of COC taken with AQX-1125
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
6 secondary outcomes
Safety and tolerability of AQX-1125 200 mg qd administered with the COC
Time frame: 16 weeks (from start of pre-treatment cycle 1 to completion of treatment period B)
Maximum observed plasma concentration (Cmax) of AQX-1125 taken with COC
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 8 Weeks (from start of treatment period A to completion of treatment period B)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2018.
Related trials for Healthy Volunteer
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeroen van de Wetering, MD principal investigator
PRA Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AQX-1125 and Combined Oral Contraceptive in people with Healthy Volunteer, run by Aquinox Pharmaceuticals (Canada) Inc. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed plasma concentration (Cmax) of COC taken with AQX-1125 (time frame: 8 Weeks (from start of treatment period A to completion of treatment period B)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2018.