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GAP-134 · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| GAP-134, IV and Oral | OTHER | Experimental; Active Comparator; Placebo |
| Name | Type | Description |
|---|---|---|
| GAP-134 | DRUG | 24-Hour IV infusion, SAD |
Inclusion Criteria * Healthy Japanese men age 20-45. * BMI within 17.6 to 26.4 kg/m2 and body weight greater than or equal to 45 kg. * Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking within 48 hours before study day 1 until the ...
GAP-134 is being studied for arrhythmia, a cardiovascular condition involving abnormal heart rhythm. It is an investigational small molecule developed by Pfizer, Inc. and has been tested in Phase 1 clinical trials. It is not yet approved for any use.
GAP-134 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the Phase 1 clinical trials of the compound in the United States and Japan.
GAP-134 is in Phase 1 clinical development. Both of its recorded trials are Phase 1 studies, and both are completed. There are no active trials of GAP-134 at this time, and the drug remains investigational.
GAP-134 has been studied in two completed Phase 1 trials. NCT00543946 evaluated a single ascending dose given as a 24-hour intravenous infusion in healthy Japanese males in Japan. NCT00510029 evaluated single ascending intravenous doses for safety, tolerability, and pharmacokinetics in the United States.
The two completed Phase 1 trials of GAP-134 enrolled a total of 128 participants. NCT00543946 enrolled 56 healthy Japanese males, and NCT00510029 enrolled 72 participants. Both studies used single ascending intravenous doses in healthy volunteers.