A Study to Evaluate GBT021601 in Single and Multiple Doses in Healthy Participants

NCT ID: NCT05036512

Last Updated: 2023-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-09

Study Completion Date

2023-02-07

Brief Summary

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This first in human study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and food effect of GBT021601, a hemoglobin S (HbS) polymerization inhibitor, in healthy participants.

Detailed Description

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This is a randomized, double-blind, placebo controlled, single and multiple ascending dose study in healthy participants.

Conditions

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Sickle Cell Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo as a tablet or capsule with dose based off of preceding cohort's data.

Group Type PLACEBO_COMPARATOR

GBT021601

Intervention Type DRUG

Administered orally with water as a single dose in the morning.

GBT021601

GBT021601 as a tablet or capsule with dose based off of preceding cohort's data.

Group Type EXPERIMENTAL

GBT021601

Intervention Type DRUG

Administered orally with water as a single dose in the morning.

Interventions

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GBT021601

Administered orally with water as a single dose in the morning.

Intervention Type DRUG

Other Intervention Names

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Placebo

Eligibility Criteria

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Inclusion Criteria

* Healthy males and females ≥ 18 to ≤ 55 years of age
* Body mass index ≥ 18.0 to ≤ 30.0 kg/m2
* Body weight ≥ 50 kg at screening and Day -1

Exclusion Criteria

\- Positive pregnancy test or currently breastfeeding.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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ICON Early Phase Services, LLC

San Antonio, Texas, United States

Site Status

Harry Perkins Institute of Medical Research

Nedlands, Western Australia, Australia

Site Status

Linear Clinical Research

Nedlands, Western Australia, Australia

Site Status

Oxford Compounding

North Perth, Western Australia, Australia

Site Status

Countries

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United States Australia

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=GBT021601-011

To obtain contact information for a study center near you, click here.

Other Identifiers

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C5351001

Identifier Type: OTHER

Identifier Source: secondary_id

GBT021601-011

Identifier Type: -

Identifier Source: org_study_id

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