NCT01638442

Crossover Trial of the Effect of a High-Fat Meal on the PK of Oral CHR 2797 in Healthy Male Subjects

An Open-label, Randomized, Two-way Crossover Trial of the Effect of a High-Fat Meal on the Pharmacokinetics of Oral Tosedostat (CHR 2797) in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: CTI BioPharma · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The objectives of this study are to evaluate the safety and tolerability; and to determine the effect of food on the pharmacokinetics (PK) of CHR-2797 in normal healthy male subjects.

Detailed description

This will be a single center, open-label, 2-arm, 2-way, crossover trial to assess the effect of food on CHR-2797 PK following a single 120 mg dose. Approximately 18 normal, healthy male subjects will be enrolled with at least 12 subjects completing the study. Two 60 mg capsules will be administered for a 120 mg dose of CHR-2797 on Days 1 and 8 with a high-fat meal or in the fasted state according to the randomization schedule. Subjects will be confined at the clinical research unit (CRU) from the time of Period 1 Check-in until Clinic Discharge on Day 3, and will return to the CRU on Day 7 for Period 2 Check-in and remain in the CRU until Study Completion (on Day 10 of Period 2). Blood samples for PK analysis will be collected through 48 hours post dose.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	CHR-2797	Two 60 mg capsules (120 mg dose) of CHR-2797 administered orally with 240 mL room temperature tap water after an approximately 10 hour fast.
DRUG	CHR-2797	Two 60 mg capsules (120 mg dose) of CHR-2792 administered orally with 240 mL room temperature tap water within 30 minutes of receiving a high-fat meal. \--------------------------------------------------------------------------------

Timeline

• Start date: 2012-06-01
• Primary completion: 2012-07-01
• Completion: 2012-09-01
• First posted: 2012-07-11
• Last updated: 2023-09-18

Locations

1 site across 1 country: United States