2023-505138-88-00CompletedPhase 1
MK-7480 Single Ascending Dose Study in Healthy Participants
A Two-Part Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of MK-7480 in Healthy Participants
Source: EU CTIS (euclinicaltrials.eu) · Last updated 18 Jan 2024
Brief summary (registry, in English)
1. To assess the safety and tolerability of single ascending oral doses of MK-7480 administered to healthy adult male participants 2. To assess the plasma PK of MK-7480 following administration of single ascending oral doses to healthy adult male participants
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- First submitted
- 16 Jun 2023
- Start date
- Aug 2023
- Lead sponsor
- Merck Sharp & Dohme LLC
- EU CT number
- 2023-505138-88-00
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 36
- 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
- A regular user of cannabis, any illicit drugs or has a history of drug (including alcohol) abuse within approximately 12 months. Participants must have a negative drug screen prior to randomization
- The participant had a major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit
- Has received any nonlive vaccine starting from 14 days prior to study intervention or is scheduled to receive any nonlive vaccine through 30 days following study intervention. Exception: COVID-19 or inactivated influenza vaccines may be administered. Study intervention must be given at least 72 hours following or at least 48 hours prior to any COVID-19 or influenza vaccination.
- Unable to refrain from or anticipates the use of any medication, including prescription and nonprescription drugs or herbal remedies beginning approximately 4 weeks prior to administration of the initial dose of study intervention, throughout the study (including washout intervals between treatment periods), until the poststudy visit
Other illness
- History of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- History of cancer (malignancy)
- Positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or HIV
Other
- Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day
- Participated in another investigational study within 4 weeks
- The participant is a smoker and/or has used nicotine or nicotine-containing products (e.g., nicotine patch and electronic cigarette) within 3 months
- Consumes greater than 3 servings of alcoholic beverages (1 serving is approximately equivalent to: beer [354 mL/12 ounces], wine [118 mL/4 ounces], or distilled spirits [29.5 mL/1 ounce]) per day
Who the study is looking for
- Be in good health
- Body Mass Index (BMI) of 18-32 kg/m2
- Assigned male sex at birth
- Abstains from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent or uses a protocol-defined method of contraception
- Willing to comply with the study restrictions
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 |
|---|---|---|---|
| Universitair Ziekenhuis Gent | Gent | Belgium | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.