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NCT05036512 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate GBT021601 in Single and Multiple Doses in Healthy Participants
A Phase 1 study of Sickle Cell Disease, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 129
- Enrollment target
- 4
- Study locations
NCT05036512: Completed Phase 1 study of Sickle Cell Disease, sponsored by Pfizer.
NCT05036512 is a Phase 1 study of Sickle Cell Disease that has completed, run by Pfizer. The registered enrollment target is 129 participants, below the 292-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (56% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05036512, a Phase 1 study of Sickle Cell Disease, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 129 participants
- Enrollment target
- 4
- Study locations
Study Summary
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.
Primary Outcome
AEs will be coded to system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA) and summarized.
Conditions Studied
Interventions
- DRUG GBT021601
Study Locations (4)
Western Australia
- Harry Perkins Institute of Medical Research - Nedlands
- Linear Clinical Research - Nedlands
- Oxford Compounding - North Perth
Texas
- ICON Early Phase Services, LLC - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2020-12-09 |
| Est. Completion | 2023-02-07 |
| Phase | Phase 1 |
What the finished NCT05036512 record still lists
NCT05036512 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, below the 292-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (56% lower).
The record links to 1 condition, with Sickle Cell Disease appearing as the primary indexed condition, and to 1 intervention - of which GBT021601 is the first listed.
NCT05036512 reports a single indexed study location in Western Australia, Texas.
Frequently Asked Questions
What is clinical trial NCT05036512 about?
NCT05036512 is a clinical study titled "A Study to Evaluate GBT021601 in Single and Multiple Doses in Healthy Participants". 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.
What is the current status of trial NCT05036512?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 129 participants. The study started on 2020-12-09. Estimated completion is 2023-02-07.
What conditions does trial NCT05036512 study?
This clinical trial studies the following conditions: Sickle Cell Disease.
What interventions are being tested in trial NCT05036512?
The interventions under investigation include: GBT021601 (DRUG).
Who is sponsoring clinical trial NCT05036512?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05036512 being conducted?
This trial has 4 study locations across Texas, Western Australia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05036512's enrollment target sits among peer trials
129 50th of 213 higher than 164 of 213 other Sickle Cell Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sickle Cell Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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