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Single-Dose PK Study of GBT440 in Subjects With Renal Impairment

NCT03161015 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2018-02-22

No results posted yet for this study

Summary

A Phase 1, multiple center, nonrandomized, open-label, parallel group study of a single oral dose of GBT440 administered in subjects with mild, moderate, or severe renal impairment disease and healthy subjects with normal renal function.

Conditions

  • Renal Impairment

Interventions

DRUG

GBT440

Oral

Sponsors & Collaborators

  • Global Blood Therapeutics

    lead INDUSTRY

Principal Investigators

  • Carla Washington · Global Blood Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-05-25
Completion
2017-07-06
FDA Drug
Yes

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 NCT03161015 on ClinicalTrials.gov