Human Immunodeficiency Virus (HIV)Phase 1NCT06783192
A Drug-Drug Interaction Study of MK 8527 With a Combined Oral Contraceptive (LNG/EE)
A Phase 1 study testing MK-8527 and LNG/EE in people with Human Immunodeficiency Virus (HIV) and HIV Pre-Exposure Prophylaxis, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
This study is designed to assess the effect of a single dose of MK-8527 on the single-dose pharmacokinetics (PK) and the safety and tolerability of levonorgestrel/ethinyl estradiol (LNG/EE) in healthy adult postmenopausal or ovariectomized female participants. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis
- What is being tested?
- MK-8527 and LNG/EE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2023to 11 Oct 2023
- 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 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- is in good overall health
- assigned female at birth
Who cannot join
- has a history of clinically significant endocrine, GI, cardiovascular, hematological, thromboembolic, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder of the last 5 years
- has a history of cancer (malignancy)
Trial locations and contacts
1 site in 1 country.
United States1 site
QPS-MRA, LLC-Early Phase (Site 0001)
South Miami, Florida, 33143
About this study
Official title: A Study to Assess the Effects of Single Oral Doses of MK-8527 on the Single-Dose Pharmacokinetics of an Oral Contraceptive (Levonorgestrel and Ethinyl Estradiol) in Healthy Adult Postmenopausal or Oophorectomized Female Subjects
This study is designed to assess the effect of a single dose of MK-8527 on the single-dose pharmacokinetics (PK) and the safety and tolerability of levonorgestrel/ethinyl estradiol (LNG/EE) in healthy adult postmenopausal or ovariectomized female participants.
- Being tested
- MK-8527, LNG/EE
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-8527Drug
MK-8527 capsule taken by mouth
LNG/EEDrug
Also called levonorgestrel/ethinyl estradiol
LNG/EE combination tablet taken by mouth.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: All Participants | Experimental | Participants receive single doses of LNG/EE alone and in combination with a single dose of MK-8527. Receives: Drug: MK-8527; Drug: LNG/EE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve from dosing to infinity (AUC0-∞) of LNG alone and with MK-8527
Measured: Up to ~96 hours postdose
Maximum plasma concentration (Cmax) of LNG alone and with MK-8527
Measured: Up to ~96 hours postdose
Time to Cmax (Tmax) of LNG alone and with MK-8527
Measured: Up to ~96 hours postdose
Apparent half-life (t½) of LNG alone and with MK-8527
Measured: Up to ~96 hours postdose
AUC0-∞ of EE alone and with MK-8527
Measured: Up to ~72 hours postdose
Tmax of EE alone and with MK-8527
Measured: Up to ~72 hours postdose
Secondary outcomes (2)
Percentage of participants with ≥1 adverse event (AE)
Measured: Up to ~28 days
Percentage of participants discontinuing from study therapy due to AE
Measured: Up to ~28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start14 Aug 2023
- Primary completion11 Oct 2023
- Study completion11 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus (HIV)Studies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783192
- Sponsor's protocol ID
- 8527-006
- Status last verified
- Jan 2025
- First submitted
- 14 Jan 2025
- Last updated
- 20 Jan 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Effects of Single Oral Doses of MK-8527 on the Single-Dose Pharmacokinetics of an Oral Contraceptive (Levonorgestrel and Ethinyl Estradiol) in Healthy Adult Postmenopausal or Oophorectomized Female Subjects
- ClinicalTrials.gov ID
- NCT06783192
- Acronym / sponsor ID
- 8527-006
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 11 Oct 2023 (actual)
- Study completion
- 11 Oct 2023 (actual)
- First posted
- 20 Jan 2025 (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 study is designed to assess the effect of a single dose of MK-8527 on the single-dose pharmacokinetics (PK) and the safety and tolerability of levonorgestrel/ethinyl estradiol (LNG/EE) in healthy adult postmenopausal or ovariectomized female participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1: All Participants | Experimental | Drug: MK-8527, Drug: LNG/EEParticipants receive single doses of LNG/EE alone and in combination with a single dose of MK-8527. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- is in good overall health
- assigned female at birth
Key exclusion criteria (3 listed)
- has a history of clinically significant endocrine, GI, cardiovascular, hematological, thromboembolic, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder of the last 5 years
- has a history of cancer (malignancy)
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 |
|---|---|---|
| MK-8527MK-8527 capsule taken by mouth | Drug | Arm 1: All Participants |
| LNG/EEAlso: levonorgestrel/ethinyl estradiolLNG/EE combination tablet taken by mouth. | Drug | Arm 1: All Participants |
Primary outcome
Area under the curve from dosing to infinity (AUC0-∞) of LNG alone and with MK-8527
Time frame: Up to ~96 hours postdose
Maximum plasma concentration (Cmax) of LNG alone and with MK-8527
Time frame: Up to ~96 hours postdose
Time to Cmax (Tmax) of LNG alone and with MK-8527
Time frame: Up to ~96 hours postdose
Apparent half-life (t½) of LNG alone and with MK-8527
Time frame: Up to ~96 hours postdose
AUC0-∞ of EE alone and with MK-8527
Time frame: Up to ~72 hours postdose
Tmax of EE alone and with MK-8527
Time frame: Up to ~72 hours postdose
2 secondary outcomes
Percentage of participants with ≥1 adverse event (AE)
Time frame: Up to ~28 days
Percentage of participants discontinuing from study therapy due to AE
Time frame: Up to ~28 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 20 Jan 2025.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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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.
Medical Director study director
Merck Sharp & Dohme LLC
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 MK-8527 and LNG/EE in people with Human Immunodeficiency Virus (HIV) and HIV Pre-Exposure Prophylaxis, run by Merck Sharp & Dohme LLC 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 2 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 20 Jan 2025. 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?
Area under the curve from dosing to infinity (AUC0-∞) of LNG alone and with MK-8527 (time frame: Up to ~96 hours postdose). The study lists 6 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 20 Jan 2025.