PK and Safety Study of AG-221 in Healthy Male Japanese Subjects and Healthy Male Caucasian Subjects

NCT02387866 | Completed Phase 1

• 1 other identifier: AG-221-CP-001
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single ascending dose, open-label study that will evaluate the pharmacokinetics and safety of the AG-221 compound in normal, healthy volunteer male subjects (both Japanese and Caucasian).

Conditions

Healthy

Keywords

Pharmacokinetic; Healthy Volunteers; Male; Japanese; Caucasian; AG-221

Outcome Measures

Primary Outcomes (7)

• Pharmacokinetics -AUC 0-t

  Area under the plasma concentration-time curve from time zero to time t

  Up to 3 days

• Pharmacokinetics - AUC ∞

  Area under the plasma concentration-time curve from time zero extrapolated to infinity

  Up to 3 days

• Pharmacokinetics - Cmax

  Maximum observed plasma concentration

  Up to 3 days

• Pharmacokinetics - Tmax

  Time to maximum observed plasma concentration

  Up to 3 days

• Pharmacokinetics -T1/2

  Estimate of the terminal elimination half-life in plasma

  Up to 3 days

• Pharmacokinetics -CL/F

  Apparent total plasma clearance when dosed orally

  Up to 3 days

• Pharmacokinetics -Vz/f

  Apparent volume of distribution during terminal phase

  Up to 3 days

Secondary Outcomes (1)

• Adverse Events (AEs)

  Approximately 28 days

Study Arms (3)

50 mg AG-221 tablet

EXPERIMENTAL

50 mg AG-221 tablet given by mouth with 240 mL of non-carbonated, room temperature water, under fasted conditions

Drug: AG-221

100 mg AG-221 tablet

EXPERIMENTAL

100 mg AG-221 tablet given by mouth with 240 mL of non-carbonated, room temperature water, under fasted conditions

Drug: AG-221

300 mg AG-221 tablet

EXPERIMENTAL

300 mg AG-221 tablet given by mouth with 240 mL of non-carbonated, room temperature water, under fasted conditions

Drug: AG-221

Interventions

AG-221 DRUG

100 mg AG-221 tablet; 300 mg AG-221 tablet; 50 mg AG-221 tablet

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must satisfy the following criteria to be enrolled in the study:
• Applicable to Japanese Subjects Only
• Must have been born in Japan to both a Japanese mother and father and also have maternal and paternal Japanese grandparents.
• Must understand and voluntarily sign an Informed Consent Form (ICF) written in English and Japanese prior to any study related procedures being performed and be able to adhere to restrictions and examination schedules.
• Applicable to Caucasian Subjects Only
• Must understand and voluntarily sign a written Informed Consent Form (ICF) prior to any study related procedures being performed and be able to adhere to restrictions and examination schedules.
• Non-Japanese subjects must be Caucasian. Caucasian is defined as being of European or Latin American descent (ie, White).
• Applicable to All Subjects
• Healthy male subjects between 20 to 50 years of age (inclusive)
• Must be able to communicate with the Investigator and understand and comply with the requirements of the study.
• Must be in good health as determined by the Investigator according to past medical history, physical examination, vital signs, electrocardiogram (ECG), and laboratory tests.
• Must have a body mass index (BMI) between 18 and 30 kg/m2 (inclusive).
• Clinical laboratory tests must be within normal limits or considered by the Investigator to be not clinically significant.
• Vital signs (systolic and diastolic blood pressure, pulse rate, and oral body temperature) will be assessed in the supine position after the subject has rested for at least 5 minutes. Subject must be afebrile (febrile is defined as ≥ 38 °C or 100.3° F) with vital signs within the following ranges:
• Systolic blood pressure: 90 to 140 mm Hg

You may not qualify if:

• The presence of any of the following will exclude a subject from enrollment:
• Any serious medical condition, clinically significant laboratory abnormality, or psychiatric illness that would prevent the subject from signing the ICF and/or participating in the study.
• Recent history (ie, within 3 years prior to dosing) of any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological or other major disorders.
• Used any prescribed systemic or topical medication within 30 days of the first dose administration.
• Used any non-prescribed systemic or topical medication (including herbal medicines, eg, St. John's Wort) within 7 days of the first dose administration (with the exception of vitamin/mineral supplements).
• Subjects who have any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism and excretion (ADME) or subjects who plan to have any elective or medical procedures during the conduct of the trial.
• Exposure to an investigational drug (new chemical entity) within 30 days prior to the first dose administration or 5 half-lives of that investigational drug, if known (whichever is longer).
• Donated blood or plasma within 8 weeks preceding the first dose administration.
• History of multiple drug allergies (ie, 2 or more).
• Any clinically significant allergic disease.
• History of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual \[DSM\]) within 2 years prior to dosing, or positive drug screening test due to illicit drugs.
• History of alcohol abuse within 2 years prior to dosing, or positive alcohol screen.
• Subjects who smoke more than 10 cigarettes or consume the equivalent in tobacco per day.
• Known to have hepatitis, or known to be a carrier of the HBsAg, or HCV Ab, or have a positive result to the test for HBsAg, HCV Ab, or HIV antibodies at Screening.

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

Parexel International

Glendale, California, 91206, United States

Location

MeSH Terms

Interventions

enasidenib

Study Officials

• Edward O'Mara, MD

  Celgene Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: March 5, 2015
• First Posted: March 13, 2015
• Study Start: March 2, 2015
• Primary Completion: May 21, 2015
• Study Completion: July 27, 2015
• Last Updated: October 30, 2018

Record last verified: 2018-10

Locations

US (1)