Study to Evaluate the Pharmacokinetics, Safety, and QTc Effect of AG-348 in Healthy Subjects of Japanese Origin and Non-Asian Origin

NCT03250598 | Completed Phase 1 FDA Drug

• 1 other identifier: AG348-C-004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this Phase I, single-dose, open-label trial is to evaluate the pharmacokinetics, safety, and effect on QTc interval of AG-348 in healthy, adult Japanese and Non-Asian subjects. The study plans to evaluate 3 cohorts of a single oral dose of AG-348 in Japanese and Non-Asian subjects. Pharmacokinetic sampling will take place serially at specified times during conduct of the study.

Conditions

Healthy; Japanese; Non-Asian

Keywords

Healthy; Japanese

Outcome Measures

Primary Outcomes (2)

• AUC

  AG-348 Area Under the Curve

  Pharmacokinetic sampling for AG-348 will be taken for 72 hours (4 days) after single dose

• Cmax

  AG-348 Maximum Plasma Concentration

  Pharmacokinetic sampling for AG-348 will be taken for 72 hours (4 days) after single dose

Secondary Outcomes (2)

• Incidence of Adverse Events

  10 (± 1) days after single-dose of AG-348

• QTc interval

  Change in QTc from baseline will be presented by race and by cohort

Study Arms (3)

Cohort A

EXPERIMENTAL

Drug: AG-348

Cohort B

EXPERIMENTAL

Drug: AG-348

Cohort C

EXPERIMENTAL

Drug: AG-348

Interventions

AG-348 DRUG

50 mg single-dose

Cohort A

Eligibility Criteria

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

You may qualify if:

• Be a male or female aged 18 to 55 years, inclusive.
• Have a body mass index (BMI) of ≥ 18.5 to ≤ 29.0 kg/m2 at Screening.
• Be healthy overall with no clinically significant medical abnormalities, as determined by the Investigator through evaluation of the subject's medical history and Screening vital signs, ECG, physical examination, and laboratory assessments.
• Applicable to Japanese Subjects Only: Japanese subjects must have been born in Japan, have both parents and all grandparents of Japanese origin, and not have lived outside of Japan for more than 5 years with no significant changes in lifestyle, including diet, since leaving Japan.
• Applicable to Non-Asian Subjects Only: Non-Asian subjects must have both parents and all grandparents of Non-Asian origin.

You may not qualify if:

• Have undergone any major surgical procedure within the 3 months prior to Screening.
• Test positive at Screening for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), or human immunodeficiency virus (HIV).
• Have a Screening systolic blood pressure (BP) reading of \> 140 mmHg (\> 150 mmHg in subjects \> 45 years of age) OR a diastolic BP reading of \> 90 mmHg after 5 minutes of supine rest.
• Have any of the following cardiac risk factors:
• Be taking any medication with a known effect of QT interval prolongation (see list of medications in Appendix 1)
• Have a cardiac pacemaker
• Demonstrate on either the Screening ECG or the baseline ECG any evidence of atrial fibrillation, atrial flutter, complete right or left bundle branch block, or Wolff-Parkinson-White syndrome
• Demonstrate on the Screening ECG any morphology that renders measurement of QT interval imprecise (eg, neuromuscular artifact that cannot be readily eliminated, indistinct QRS onset, low-amplitude T wave, merged T and U waves, prominent U waves, arrhythmia)
• Have a history of a known risk factor for Torsade de Pointes, including any of the following:
• Personal or family history of congenital long QT syndrome, Brugada syndrome, or sudden death
• Unexplained syncope
• Heart failure
• Myocardial infarction
• Angina
• Certain clinically significant laboratory assessment findings, including hypokalemia, hypercalcemia, or hypomagnesemia

Sponsors & Collaborators

• Agios Pharmaceuticals, Inc.: lead

Study Sites (1)

West Coast Clinical Trial (WCCT) Global, Inc.

Cypress, California, 90630, United States

Location

MeSH Terms

Interventions

mitapivat

Study Officials

• Medical Affairs Agios Pharmaceuticals, Inc

  Agios Pharmaceuticals, Inc.

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: August 11, 2017
• First Posted: August 15, 2017
• Study Start: August 9, 2017
• Primary Completion: October 2, 2017
• Study Completion: October 9, 2017
• Last Updated: October 19, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)