Healthy VolunteersPhase 1NCT06250205
Evaluate the Pharmacokinetics of a Combined Oral Contraceptive (COC) With and Without Obicetrapib
A Phase 1 study testing Obicetrapib, Obicetrapib + Drospirenone / Ethinyl Estradiol (COC) and Drospirenone / Ethinyl Estradiol (COC) in people with Healthy Volunteers, run by NewAmsterdam Pharma at 1 site in United States.
Trial summary
A study to evaluate the impact of Obicetrapib on the PK levels of Drospirenone and Ethinyl Estradiol (COC) in 30 adult female, healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Obicetrapib, Obicetrapib + Drospirenone / Ethinyl Estradiol (COC) and Drospirenone / Ethinyl Estradiol (COC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2024to 26 Apr 2024
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-pregnant, non-lactating, non-tobacco-, non-nicotine-using female, 18-35 years of age, inclusive, who is a candidate for hormonal contraception (as determined by the Investigator).
- Subject has a BMI of 18.5-29.9 kg/m², inclusive. BMI will be calculated using Novum Pharmaceutical Research Services Standard Operating Procedures.
- If the subject is currently using a hormonal method of contraception, the subject is willing and agrees to stop using her hormonal contraceptive throughout the duration of the study and is prepared to abstain from sexual intercourse or use a reliable non-hormonal method of contraception, as outlined below
Who cannot join
- Male
- Have given birth or been pregnant within 3 months before initial dosing, or is currently pregnant, lactating or likely to become pregnant during the study.
- History of Hypertension, or seated blood pressure for a minimum of 5 minutes >140mmHg systolic, or > 80 mmHg, diastolic at screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Effect of Daily Doses of Obicetrapib Tablets on the Pharmacokinetics of Drospirenone and Ethinyl Estradiol in Healthy Adult Female Subjects
A study to evaluate the impact of Obicetrapib on the PK levels of Drospirenone and Ethinyl Estradiol (COC) in 30 adult female, healthy volunteers.
Read the detailed description
This is an interventional, drug-drug interaction study to evaluate the effect of daily doses of Obicetrapib tablets on the pharmacokinetics of a combined oral contraceptive (COC), Drospirenone and Ethinyl Estradiol.
- Conditions
- Healthy Volunteers
- Being tested
- Obicetrapib, Obicetrapib + Drospirenone / Ethinyl Estradiol (COC), Drospirenone / Ethinyl Estradiol (COC)
- Keywords
- DDI, drug-drug interaction, combined oral contraceptive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObicetrapibDrug
Also called 10 mg tablet
oral administration
Obicetrapib + Drospirenone / Ethinyl Estradiol (COC)Drug
Also called tablets
oral administration
Drospirenone / Ethinyl Estradiol (COC)Drug
Also called tablets
oral administration
| Study group | Role | What they receive |
|---|---|---|
| Treatment B+C: Obicetrapib + Drospirenone/Ethinyl Estradiol (COC) | Experimental | Obicetrapib 10 mg tablets and Drospirenone (3mg)/Ethinyl Estradiol (0.02mg) tablet Receives: Drug: Obicetrapib; Drug: Obicetrapib + Drospirenone / Ethinyl Estradiol (COC) |
| Treatment B: Obicetrapib | Experimental | Obicetrapib 10 mg tablets (daily) Receives: Drug: Obicetrapib |
| Treatment C: Drospirenone/Ethinyl Estradiol tablets (COC) | Experimental | Drospirenone (3mg)/Ethinyl Estradiol tablets (0.02mg) tablet Receives: Drug: Drospirenone / Ethinyl Estradiol (COC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) of COC
Plasma Cmax concentration of COC with and without Obicetrapib
Measured: Upon completion of Treatment C (Day -6) and Treatments B+C (Day 12)
Area under the plasma concentration-time (AUC0-τ) curve for COC with and without coadministration with Obicetrapib
Plasma AUC0-τ for COC with and without coadministration of Obicetrapib
Measured: Upon completion of Treatment C (Day -6) and Treatments B+C (Day 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start5 Feb 2024
- Primary completion25 Apr 2024
- Study completion26 Apr 2024
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Open-label, multiple-dose, fixed sequence, drug-drug interaction study.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- NewAmsterdam Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novum
- Responsible party
- Sponsor
- Investigators
- Kent A Swaine, Principal investigator, Novum Pharmaceutical Research Services, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250205
- Sponsor's protocol ID
- TA-8995-13
- Status last verified
- Sep 2024
- First submitted
- 1 Feb 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Effect of Daily Doses of Obicetrapib Tablets on the Pharmacokinetics of Drospirenone and Ethinyl Estradiol in Healthy Adult Female Subjects
- ClinicalTrials.gov ID
- NCT06250205
- Acronym / sponsor ID
- TA-8995-13
- Conditions
- Healthy Volunteers
- Keywords
- DDI, drug-drug interaction, combined oral contraceptive
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- NewAmsterdam PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Novum
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 26 Apr 2024 (actual)
- First posted
- 8 Feb 2024 (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.
A study to evaluate the impact of Obicetrapib on the PK levels of Drospirenone and Ethinyl Estradiol (COC) in 30 adult female, healthy volunteers.
Detailed description
This is an interventional, drug-drug interaction study to evaluate the effect of daily doses of Obicetrapib tablets on the pharmacokinetics of a combined oral contraceptive (COC), Drospirenone and Ethinyl Estradiol.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Open-label, multiple-dose, fixed sequence, drug-drug interaction study.
| Arm | Type | Receives |
|---|---|---|
| Treatment B+C: Obicetrapib + Drospirenone/Ethinyl Estradiol (COC) | Experimental | Drug: Obicetrapib, Drug: Obicetrapib + Drospirenone / Ethinyl Estradiol (COC)Obicetrapib 10 mg tablets and Drospirenone (3mg)/Ethinyl Estradiol (0.02mg) tablet |
| Treatment B: Obicetrapib | Experimental | Drug: ObicetrapibObicetrapib 10 mg tablets (daily) |
| Treatment C: Drospirenone/Ethinyl Estradiol tablets (COC) | Experimental | Drug: Drospirenone / Ethinyl Estradiol (COC)Drospirenone (3mg)/Ethinyl Estradiol tablets (0.02mg) tablet |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Non-pregnant, non-lactating, non-tobacco-, non-nicotine-using female, 18-35 years of age, inclusive, who is a candidate for hormonal contraception (as determined by the Investigator).
- Subject has a BMI of 18.5-29.9 kg/m², inclusive. BMI will be calculated using Novum Pharmaceutical Research Services Standard Operating Procedures.
- If the subject is currently using a hormonal method of contraception, the subject is willing and agrees to stop using her hormonal contraceptive throughout the duration of the study and is prepared to abstain from sexual intercourse or use a reliable non-hormonal method of contraception, as outlined below
Key exclusion criteria (3 listed)
- Male
- Have given birth or been pregnant within 3 months before initial dosing, or is currently pregnant, lactating or likely to become pregnant during the study.
- History of Hypertension, or seated blood pressure for a minimum of 5 minutes >140mmHg systolic, or > 80 mmHg, diastolic at screening
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 |
|---|---|---|
| ObicetrapibAlso: 10 mg tabletoral administration | Drug | Treatment B+C: Obicetrapib + Drospirenone/Ethinyl Estradiol (COC), Treatment B: Obicetrapib |
| Obicetrapib + Drospirenone / Ethinyl Estradiol (COC)Also: tabletsoral administration | Drug | Treatment B+C: Obicetrapib + Drospirenone/Ethinyl Estradiol (COC) |
| Drospirenone / Ethinyl Estradiol (COC)Also: tabletsoral administration | Drug | Treatment C: Drospirenone/Ethinyl Estradiol tablets (COC) |
Primary outcome
Maximum observed plasma concentration (Cmax) of COC
Time frame: Upon completion of Treatment C (Day -6) and Treatments B+C (Day 12)
Plasma Cmax concentration of COC with and without Obicetrapib
Area under the plasma concentration-time (AUC0-τ) curve for COC with and without coadministration with Obicetrapib
Time frame: Upon completion of Treatment C (Day -6) and Treatments B+C (Day 12)
Plasma AUC0-τ for COC with and without coadministration of Obicetrapib
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 19 Sep 2024.
- 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.
Kent A Swaine principal investigator
Novum Pharmaceutical Research Services, Inc.
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 Obicetrapib, Obicetrapib + Drospirenone / Ethinyl Estradiol (COC) and Drospirenone / Ethinyl Estradiol (COC) in people with Healthy Volunteers, run by NewAmsterdam Pharma 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 3 inclusion and 3 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 19 Sep 2024. 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?
Maximum observed plasma concentration (Cmax) of COC (time frame: Upon completion of Treatment C (Day -6) and Treatments B+C (Day 12)). The study lists 2 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 19 Sep 2024.