Healthy VolunteersPhase 1NCT04309643
Drug-drug Interaction Study of CTP-543 and Oral Contraceptives in Healthy Female Subjects
A Phase 1 study testing CTP-543 and Combined oral contraceptive containing Ethinyl estradiol (EE) and Levonorgestrel (LNG) in people with Healthy Volunteers, run by Concert Pharmaceuticals at 1 site in United States.
Trial summary
This is a Phase 1, fixed sequence, multiple dose, open-label study of the effect of CTP-543 on oral contraceptive pharmacokinetics in healthy female subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- CTP-543 and Combined oral contraceptive containing Ethinyl estradiol (EE) and Levonorgestrel (LNG)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2020to 8 Jul 2020
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy female participants of non-childbearing potential, or adult females of childbearing potential who agree to use birth control methods described in the protocol
- If of reproductive age, willing and able to use a medically highly effective form of birth control 28 days prior to first dose, during the study and for 28 days following last dose of study medication. Examples of medically highly effective forms of birth control are:
- Surgical sterilization of the partner (via vasectomy, hysterectomy, bilateral tubal ligation or bilateral salpingectomy) at least 4 months prior to first dose or post-menopausal with amenorrhea for at least 1 year prior to the first dosing and follicle-stimulating hormone (FSH) serum levels (> 40 IU/L) consistent with postmenopausal status
- Sexual partner is sterile, or of the same sex
- Double-barrier method (any combination of physical and chemical methods)
- Non-hormone releasing intrauterine device in females
Show all 10Show fewer
- Continuous non smoker who has not used nicotine containing products for at least 3 months prior to the first dosing and throughout the study
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2
- Medically healthy with no clinically significant medical history, physical examination, laboratory tests, vital signs, or ECGs
- Understands the study procedures in the informed consent form, and be willing and able to comply with the protocol
Who cannot join
- Positive pregnancy test
- History or presence of clinically significant medical or psychiatric condition or disease
- History of any illness that might confound the results of the study or pose an additional risk to the subject by their participation in the study
- History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing
- A positive tuberculosis test at screening or history of incompletely treated or untreated tuberculosis
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
- Donation of blood or significant blood loss within 56 days prior to dosing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label Study to Assess the Effect of CTP-543 on the Pharmacokinetics of Oral Contraceptives in Healthy Adult Female Subjects
This is a Phase 1, fixed sequence, multiple dose, open-label study of the effect of CTP-543 on oral contraceptive pharmacokinetics in healthy female subjects.
- Conditions
- Healthy Volunteers
- Being tested
- CTP-543, Combined oral contraceptive containing Ethinyl estradiol (EE) and Levonorgestrel (LNG)
- Keywords
- Oral contraceptive, Drug-drug Interaction, CTP-543
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTP-543Drug
Investigational Drug
Combined oral contraceptive containing Ethinyl estradiol (EE) and Levonorgestrel (LNG)Drug
Oral contraceptive in the form of 1 fixed combination tablet of Seasonique or generic equivalent (0.03 mg EE / 0.15 mg LNG)
| Study group | Role | What they receive |
|---|---|---|
| CTP-543 | Experimental | In Period 1, participants will receive a single oral dose of the combination oral contraceptive (OC) on Day 1. There will be a washout period of 7 days between dosing in Period 1 and the first dose in Period 2. In Period 2, participants will receive twice daily oral doses of CTP-543 for 8 consecutive days with a single dose of the combination OC co-administered on Day 4. Receives: Drug: CTP-543; Drug: Combined oral contraceptive containing Ethinyl estradiol (EE) and Levonorgestrel (LNG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t
Area Under the Plasma Concentration-Time Profile
Measured: From the start of Period 1 to completion of Period 2 (16 days)
AUC0-inf
Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time
Measured: From the start of Period 1 to completion of Period 2 (16 days)
Cmax
Maximum observed concentration of drug in plasma
Measured: From the start of Period 1 to completion of Period 2 (16 days)
Secondary outcomes (5)
Number of Participants with Adverse Events (AEs)
An adverse event is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention
Measured: Up to 58 days
Number of Participants With Clinically Significant Change in Vital Signs
Blood pressure, heart rate, respiratory rate, and temperature
Measured: Up to 44 days
Number of Participants With Clinically Significant Change in Clinical Laboratory Evaluations
Hematology, serum chemistry, coagulation, and urinalysis
Measured: Up to 44 days
Number of Participants With Clinically Significant Change to the Physical Examination
Symptom-driven physical examinations may be performed at other times, if deemed necessary
Measured: Screening (Day -28)
Number of Participants With Clinically Significant Change in Electrocardiogram
12-Lead ECG
Measured: Up to 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start9 Jun 2020
- Primary completion25 Jun 2020
- Study completion8 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Other
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Concert Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309643
- Sponsor's protocol ID
- CP543.1005
- Status last verified
- Jul 2020
- First submitted
- 11 Mar 2020
- Last updated
- 16 Jul 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study to Assess the Effect of CTP-543 on the Pharmacokinetics of Oral Contraceptives in Healthy Adult Female Subjects
- ClinicalTrials.gov ID
- NCT04309643
- Acronym / sponsor ID
- CP543.1005
- Conditions
- Healthy Volunteers
- Keywords
- Oral contraceptive, Drug-drug Interaction, CTP-543
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Concert PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- 9 Jun 2020 (actual)
- Primary completion
- 25 Jun 2020 (actual)
- Study completion
- 8 Jul 2020 (actual)
- First posted
- 16 Mar 2020 (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 a Phase 1, fixed sequence, multiple dose, open-label study of the effect of CTP-543 on oral contraceptive pharmacokinetics in healthy female subjects.
Study design
- Primary purpose
- Other
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CTP-543 | Experimental | Drug: CTP-543, Drug: Combined oral contraceptive containing Ethinyl estradiol (EE) and Levonorgestrel (LNG)In Period 1, participants will receive a single oral dose of the combination oral contraceptive (OC) on Day 1. There will be a washout period of 7 days between dosing in Period 1 and the first dose in Period 2. In Period 2, participants will receive twice daily oral doses of CTP-543 for 8 consecutive days with a single dose of the combination OC co-administered on Day 4. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Healthy female participants of non-childbearing potential, or adult females of childbearing potential who agree to use birth control methods described in the protocol
- If of reproductive age, willing and able to use a medically highly effective form of birth control 28 days prior to first dose, during the study and for 28 days following last dose of study medication. Examples of medically highly effective forms of birth control are:
- Continuous non smoker who has not used nicotine containing products for at least 3 months prior to the first dosing and throughout the study
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2
- Medically healthy with no clinically significant medical history, physical examination, laboratory tests, vital signs, or ECGs
Key exclusion criteria (7 listed)
- Positive pregnancy test
- History or presence of clinically significant medical or psychiatric condition or disease
- History of any illness that might confound the results of the study or pose an additional risk to the subject by their participation in the study
- History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing
- A positive tuberculosis test at screening or history of incompletely treated or untreated tuberculosis
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 |
|---|---|---|
| CTP-543Investigational Drug | Drug | CTP-543 |
| Combined oral contraceptive containing Ethinyl estradiol (EE) and Levonorgestrel (LNG)Oral contraceptive in the form of 1 fixed combination tablet of Seasonique or generic equivalent (0.03 mg EE / 0.15 mg LNG) | Drug | CTP-543 |
Primary outcome
AUC0-t
Time frame: From the start of Period 1 to completion of Period 2 (16 days)
Area Under the Plasma Concentration-Time Profile
AUC0-inf
Time frame: From the start of Period 1 to completion of Period 2 (16 days)
Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time
Cmax
Time frame: From the start of Period 1 to completion of Period 2 (16 days)
Maximum observed concentration of drug in plasma
5 secondary outcomes
Number of Participants with Adverse Events (AEs)
Time frame: Up to 58 days
Number of Participants With Clinically Significant Change in Vital Signs
Time frame: Up to 44 days
Number of Participants With Clinically Significant Change in Clinical Laboratory Evaluations
Time frame: Up to 44 days
Number of Participants With Clinically Significant Change to the Physical Examination
Time frame: Screening (Day -28)
Number of Participants With Clinically Significant Change in Electrocardiogram
Time frame: Up to 40 days
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 16 Jul 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 CTP-543 and Combined oral contraceptive containing Ethinyl estradiol (EE) and Levonorgestrel (LNG) in people with Healthy Volunteers, run by Concert Pharmaceuticals at 1 site in United States.
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 10 inclusion and 7 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 16 Jul 2020. 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 United States. 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?
AUC0-t (time frame: From the start of Period 1 to completion of Period 2 (16 days)). The study lists 3 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 16 Jul 2020.