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
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
- collaborator INDUSTRY
-
Gates Medical Research Institute
lead OTHER
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
-
Safety, Tolerability And Pharmacokinetics Study Of Single Doses Of PNU-100480 In Healthy Adults
NCT00871949 ·Status: COMPLETED ·Phase: PHASE1
-
Phase I Clinical Protocol for Pre-evaluation of the Safety of BCG-PPD in Tuberculosis Patients
NCT04538911 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in Healthy Volunteers
NCT05537038 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1/2 Trial of Multiple Oral Doses of OPC-167832 for Uncomplicated Pulmonary Tuberculosis
NCT03678688 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Phase IC Study of Safety and PK of SQ109 300mg Daily
NCT01358162 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBA-354 in Healthy Adult Subjects
NCT02288481 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics And Measurement Of Whole Blood Activity (WBA) Of PNU-100480 After Multiple Oral Doses In Healthy Adult Volunteers
NCT00990990 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Efficacy and Safety of TMC207 in Patients With Pulmonary Infection With Multi-drug Resistant Mycobacterium Tuberculosis
NCT01600963 ·Status: WITHDRAWN ·Phase: PHASE3
-
Phase 1 Study of PBTZ169
NCT03036163 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1 Study to Evaluate Safety, Tolerability, PK, and PK Interactions of TBA-7371
NCT03199339 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Ex-vivo Antitubercular Activity of PBTZ169 Formulation
NCT03423030 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in Adults With TB Disease
NCT01424501 ·Status: TERMINATED ·Phase: PHASE2
-
A Study of the Safety, Tolerability, and Absorption, Metabolism, and Excretion of PA-824 in Healthy Adult Male Subjects.
NCT03202693 ·Status: COMPLETED ·Phase: PHASE1
-
Phase IV Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein
NCT05746611 ·Status: COMPLETED ·Phase: PHASE4
-
A Phase ⅠStudy of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried
NCT03026972 ·Status: COMPLETED ·Phase: PHASE1
-
A Multiple Ascending Dose Study With a Dose Formulation Comparison Cohort to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBA-354 in Healthy Adult Subjects
NCT02606214 ·Status: TERMINATED ·Phase: PHASE1
-
Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine Given to PPD-Negative Adults
NCT00730795 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, and Immunogenicity of the Vaccine Candidates ID93 + AP10-602 and ID93 + GLA-SE Administered Intramuscularly in Healthy Adult Subjects
NCT02508376 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase Ⅱ Clinical Trial of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried (AEC/BC02)
NCT05284812 ·Status: SUSPENDED ·Phase: PHASE2
-
Phase I Clinical Protocol of BCG-PPD in Healthy People
NCT04593771 ·Status: COMPLETED ·Phase: PHASE1
-
First-in-Human Trial of the Novel Tuberculosis Vaccine Candidate, H107e/CAF®10b
NCT06050356 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Study to Evaluate the Efficacy of GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine in Adults
NCT01755598 ·Status: COMPLETED ·Phase: PHASE2
-
PanACEA - STEP2C -01
NCT05807399 ·Status: RECRUITING ·Phase: PHASE2
-
Study on Three Doses of an Inactivated COVID-19 Vaccine in Chinese Pulmonary Tuberculosis Patients
NCT05148949 ·Status: UNKNOWN ·Phase: PHASE4
-
Single-dose Study in Two Panels of Healthy Adult Participants to Assess Immediate-Release and Dispersible Formulations of Pretomanid
NCT04309656 ·Status: COMPLETED ·Phase: PHASE1