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

NCT01638442 | Completed Phase 1

• 1 other identifier: TST101
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Male subjects, healthy

Outcome Measures

Primary Outcomes (2)

• Safety Outcome Measurement

  Report adverse events, vital signs, electrocardiograms, and clinical laboratory test. Averse events, clinical labs, and other safety variables will be analyzed descriptively for all sujects who recieve at least 1 dose of study drug.

  10 days

• Pharmacokinetic Parameter

  For each subject the following PK parameters will be calculated, whevever possible, based on the plasma concentrations of CHR-2797 and its metabolite CHR-79888: * Maximum observed concentration (Cmax) * time to maximum concentration (t-max) * area under the concentration-time curve from Hour 0 to the last measureable concentration (AUC0-t) * apparent terminal elimination rate constant * apparent terminal elimination half-life

  10 days

Secondary Outcomes (1)

• Adverse Events

  10 days

Study Arms (2)

Treatment A

EXPERIMENTAL

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

Treatment B

EXPERIMENTAL

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.

Drug: CHR-2797

Interventions

CHR-2797 DRUG

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.

Treatment A

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male subjects between 18 and 55 years of age, inclusive.
• Within BMI range of 18.5 to 29.9 kg/m2, inclusive.
• In good health, determined by no clinically significant ongoing diseases or other conditions that require medication, and/or any other findings from medical history, physical examination, 12-lead ECG, and vital signs.
• Clinical laboratory evaluations (including chemistry panel fasted \[fasted approximately 10 hours\], CBC, and UA) within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator.
• Negative test for selected drugs of abuse at Screening (does not include alcohol) and at Check-in (does include alcohol; Appendix A).
• Negative hepatitis panel (including hepatitis B surface antigen \[HBsAg\] and hepatitis C virus \[anti-HCV\], and negative HIV antibody screens (Appendix A);
• Males will either be sterile or agree to use 1 of the following approved methods of contraception: a male condom with spermicide; a sterile sexual partner; use by female sexual partner of an intrauterine device with spermicide; a female condom with spermicide; contraceptive sponge with spermicide; an intravaginal system (e.g., NuvaRing®), a diaphragm with spermicide; a cervical cap with spermicide; or oral, implantable, transdermal, or injectable contraceptives from Check-in (Day -1 of Period 1) until 90 days following Clinic Discharge (Day 10).
• Able to comprehend and willing to sign an Informed Consent Form (ICF).

You may not qualify if:

• Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the Investigator).
• Have a disease or condition that requires daily medication.
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator.
• History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (except that appendectomy, hernia repair, and/or cholecystectomy will be allowed).
• History or presence of an abnormal ECG, which, in the Investigator's opinion, is clinically significant.
• History of alcoholism or drug addiction within 1 year prior to Check-in (Day -1 of Period 1).
• Use of any tobacco- or nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to Check-in (Day -1 of Period 1).
• Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days prior to Check-in (Day -1 of Period 1).
• Use of any prescription medications/products within 14 days prior to Check-in (Day 1 of Period 1), unless deemed acceptable by the Investigator;
• Use of any over-the-counter (OTC), non-prescription preparations (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within 7 days prior to Check-in (Day -1 of Period 1), unless deemed acceptable by the Investigator.
• Use of alcohol-, grapefruit-, or caffeine-containing foods or beverages within 72 hours prior to Check-in (Day -1 of Period 1), unless deemed acceptable by the Investigator.
• Poor peripheral venous access.
• Donation of blood from 30 days prior to Screening through Study Completion, inclusive, or of plasma from 2 weeks prior to Screening through Study Completion, inclusive.
• Receipt of blood products within 2 months prior to Check-in (Day -1 of Period 1).
• Any acute or chronic condition that, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study.

Sponsors & Collaborators

• CTI BioPharma: lead
• Chroma Therapeutics: collaborator

Study Sites (1)

Covance Clinical Research Unit Inc.

Evansville, Indiana, 47710, United States

Location

MeSH Terms

Interventions

tosedostat

Study Officials

• Randall Stoltz, MD

  Covance

  PRINCIPAL INVESTIGATOR

• Simran Singh, MS, GWCPM

  CTI BioPharma

  STUDY CHAIR

• Bob Wright, PM

  Covance

  STUDY DIRECTOR

• Jack Singer, MD

  CTI BioPharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2012
• First Posted: July 11, 2012
• Study Start: June 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: September 1, 2012
• Last Updated: September 18, 2023

Record last verified: 2023-09

Locations

US (1)