NCT05716919
Active, not recruiting
Phase 1
A Phase I, Double Blind, Randomized, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Orally Administered 'Ivaltinostat' Capsule in Healthy Male Volunteers
Machaon Biotherapeutics, Inc.1 site in 1 country32 target enrollmentMarch 9, 2023
DrugsIvaltinostat
Overview
- Phase
- Phase 1
- Intervention
- Ivaltinostat
- Conditions
- Hematologic Malignancy
- Sponsor
- Machaon Biotherapeutics, Inc.
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Plasma Pharmacokinetic measures (Cmax, Cmax-ss)
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
A Phase I, Double blind, Randomized, Placebo-controlled, Multiple Ascending Dose Study to evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Orally Administered 'CG-745' Capsule in Healthy Male Volunteers
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Cohort 1 - 4
Cohort 1 : 50 mg/day Cohort 2 : 100 mg/day Cohort 3: 200mg/day \[Cohort 4: 300mg/day: based on the result of Safety Review Meeting (SRM)\]
Intervention: Ivaltinostat
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Plasma Pharmacokinetic measures (Cmax, Cmax-ss)
Time Frame: up to 4 weeks
Plasma Pharmacokinetic measures (AUC max, AUCmax-ss)
Time Frame: up to 4 weeks
Secondary Outcomes
- The Number of Participants Who Experienced Serious or Non-Serious Adverse Events(Up to 4 weeks for each dosing cohort)
Study Sites (1)
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