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A Phase 1 Study To Evaluate The Effect Of Glasdegib On The Cardiac Repolarization In Healthy Subjects

NCT03162900 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2019-09-06

No results posted yet for this study

Summary

This is a Thorough QT study intended to estimate the effect of glasdegib at therapeutic exposure and at supra-therapeutic exposure on cardiac repolarization in healthy subjects. This is a randomized, double blind, positive and placebo controlled study with a 6 day washout between successive periods.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Glasdegib Therapeutic Exposure

Subjects Receive a single 150 mg dose of Glasdegib followed by ECG and PK assessments.

DRUG

Glasdegib Supra-therapeutic Exposure

Subjects receive a single 300 mg dose of glasdegib followed by ECG and PK assessments.

DRUG

Positive Control (Moxifloxacin)

Subjects will receive a single 400 mg dose of moxifloxacin followed by ECG and PK assessments.

OTHER

Placebo Control

Subjects will receive placebo dose followed by ECG and PK assessments.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2017-06-09
Primary Completion
2017-09-23
Completion
2017-10-16

Countries

  • Belgium

Study Locations

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Entities

Companies

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 NCT03162900 on ClinicalTrials.gov