MK-5684 Food Effect Study
Key facts
- Where
- Leuven, BelgiumSee the site
- Phase
- 1. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Belgium
- UZ LeuvenLeuven, BelgiumNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- EU 2023-505521-14-00
- Record updated
- 2023. július 25.
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Has a body mass index (BMI) ≥18 kg/m^2 and ≤32 kg/m^2.
Exclusion: 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; 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; 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.