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GAP-134

Phase 1

Arrhythmia | Small molecule | Cardiovascular |Pfizer, Inc.|Last Updated: Sep 27, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment128

FDA Designations

No designations recorded

Clinical trial landscape

GAP-134 · 3 trials · 2 indications

Phase 1 3
NCT00783341Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered IntravenouslyHealthy Subjects
COMPLETED25 Analytics
NCT00543946Single Ascending Dose of GAP-134 as a 24-hour IV Infusion in Healthy Japanese MalesArrhythmia
COMPLETED56 Analytics
NCT00510029Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered IntravenouslyArrhythmia
COMPLETED72 Analytics
PHASE1COMPLETED
Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Intravenously
Healthy SubjectsUnlock trial analytics
PHASE1COMPLETED
Single Ascending Dose of GAP-134 as a 24-hour IV Infusion in Healthy Japanese Males
ArrhythmiaUnlock trial analytics
PHASE1COMPLETED
Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Intravenously
ArrhythmiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety as determined by reported adverse events, laboratory test results, and ECGs
3 weeks
The primary objective is to assess the safety and tolerability of ascending, single IV doses of GAP-134 as 24-hour continuous infusions and as a single bolus injection in healthy Japanese male subjects.
6 months
To assess the safety and tolerability of single ascending IV doses of GAP-134 administered as 24-hour continuous infusions and as single bolus injection of GAP-134 in healthy subjects
3-4 months

Secondary Endpoints

Pharmacokinetic parameters
9 days
The secondary objective is to provide the initial PK profiles of ascending single IV doses (24 hour and 1-minute) of GAP-134 taken under fasting conditions in healthy Japanese male subjects.
6 months
To provide the initial Pharmacokinetic (PK) profile of single ascending IV doses (24 hour and 1-minute) and the initial PK assessment of the bioavailability of an oral formulation of GAP-134 under fasting conditions in healthy subjects
3-4 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GAP-134EXPERIMENTAL -
placeboPLACEBO_COMPARATOR -
GAP-134, IV and OralOTHERExperimental; Active Comparator; Placebo

Interventions

NameTypeDescription
GAP-134DRUG -
placeboDRUG -
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion 1. Men or women of non childbearing potential (WONCBP) aged 18 to 50 years inclusive at screening. 2. Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight ≥50 kg. 3. Healthy as determined by the investigator on the basis of medical history, physical examination, clinic...

Countries:United StatesJapan
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Competitive Landscape -Arrhythmia 12 trials

Frequently asked questions about GAP-134

What is GAP-134 used for?

GAP-134 is an investigational small molecule being studied for the treatment of arrhythmia, a condition involving abnormal heart rhythms. It has also been evaluated in healthy subjects as part of early clinical development. The drug is administered intravenously and is currently in Phase 1 clinical trials.

Who makes GAP-134?

GAP-134 is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The company has sponsored multiple Phase 1 clinical trials to evaluate the safety, tolerability, and pharmacokinetics of the drug.

What phase is GAP-134 in?

GAP-134 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. All completed trials for GAP-134 are Phase 1 studies, indicating it is still in the early stages of clinical testing.

What clinical trials is GAP-134 in?

GAP-134 has been studied in three completed Phase 1 clinical trials. These include NCT00510029, a single ascending dose study in the United States with 72 participants; NCT00543946, a study in healthy Japanese males with 56 participants; and NCT00783341, a study in healthy subjects with 25 participants.

How does GAP-134 work?

The mechanism of action for GAP-134 has not been disclosed in the available information. As a small molecule being investigated for arrhythmia, it is believed to interact with cardiac targets, but specific molecular targets have not been publicly identified.

Is GAP-134 the same as any other drug?

No alternative names for GAP-134 have been identified in the available information. The drug is referred to solely as GAP-134 in clinical trial records and development documentation.