2023-505521-14-00CompletedPhase 1
MK-5684 Food Effect Study
A Single-Dose Two-Period Crossover Study to Assess the Effect of Food on MK-5684 Pharmacokinetics and to Monitor Pharmacodynamic Effects Over Time in Healthy Participants
Source: EU CTIS (euclinicaltrials.eu) · Last updated 25 Jul 2023
Brief summary (registry, in English)
1. To evaluate the effect of a high-fat meal on the plasma pharmacokinetics of MK-5684 as compared to the plasma pharmacokinetics in the fasted state after administration of a single oral 5-mg dose of MK-5684 in healthy male participants. 2. To assess the effect of MK-5684 on steroid hormone levels over time in healthy male participants.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 14 (actual)
- First submitted
- 12 Jun 2023
- Start date
- 2 Aug 2023
- Lead sponsor
- Merck Sharp & Dohme LLC
- EU CT number
- 2023-505521-14-00
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 14
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Is unable to refrain from or anticipates the use of any medication, including prescription and nonprescription drugs or herbal remedies beginning at least 2 weeks prior to administration of the initial dose of the study intervention, throughout the study, until the poststudy visit
- Has received or expected to receive any form of vaccination within 2 weeks of pre-study, throughout the study and poststudy
Other illness
- Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases
- Is a regular user of cannabis, any illicit drugs or has a history of drug abuse within approximately 12 months
- Has a history of cancer
- Has a history of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food
- Has positive test(s) for hepatitis B surface antigen (HBs Ag), hepatitis C antibodies or human immunodeficiency virus (HIV) serologies
Other
- The investigator has any concern regarding safe participation in the study or for any other reason the investigator considers the participant inappropriate for participation in the study
- Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study
- Has any contraindications to prednisone and fludrocortisone
- Is a smoker and/or used nicotine or nicotine containing products within 3 months of screening
- Consumes greater than 3 servings of alcoholic beverages as per protocol per day. Participants who consume 4 servings of alcoholic beverages per day may be enrolled at the discretion of the investigator
Who the study is looking for
- Has a body mass index (BMI) ≥18 kg/m^2 and ≤32 kg/m^2
Age in the registry: 18 years to 64 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Leuven | Leuven | Belgium | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.