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

NCT01638442 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-09-18

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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. \--------------------------------------------------------------------------------

Sponsors & Collaborators

  • Chroma Therapeutics

    collaborator INDUSTRY

  • CTI BioPharma

    lead INDUSTRY

Principal Investigators

  • Randall Stoltz, MD · Covance

  • Simran Singh, MS, GWCPM · CTI BioPharma

  • Bob Wright, PM · Covance

  • Jack Singer, MD · CTI BioPharma

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2012-07-31
Completion
2012-09-30

Countries

  • United States

Study Locations

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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 NCT01638442 on ClinicalTrials.gov