Safety, Tolerability, Pharmacokinetics (PK), and Food Effect of MK-7762 in Healthy Adults

NCT05824091 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2024-07-26

No results posted yet for this study

Summary

The goal of this clinical trial is to assess the safety, tolerability, and pharmacokinetics of single and then multiple doses of MK-7762 (TBD09) in healthy volunteers in the context of a first-in-human study. The effect of food on the rate and extent of absorption of a single oral dose of MK-7762 (TBD09) will also be evaluated.

Conditions

Interventions

DRUG

MK-7762 (TBD09)

Cohort 1: 50 mg Cohort 2: 150 mg Cohort 3: 300 mg Cohort 4: 600 mg Cohort 5: TBD Cohort 6: TBD

OTHER

Placebo

A subset of participants from each of the 6 dosing cohorts will receive placebo.

Sponsors & Collaborators

Principal Investigators

  • Gates MRI · Gates MRI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-23
Primary Completion
2024-03-26
Completion
2024-03-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05824091 on ClinicalTrials.gov