NCT00543946 is a Phase 1 clinical trial of GAP-134 in Arrhythmia, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.

Who is sponsoring NCT00543946?

NCT00543946 is sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.

What drugs are being tested in NCT00543946?

Interventions in NCT00543946: GAP-134.

What condition does NCT00543946 study?

NCT00543946 studies Arrhythmia.

Is NCT00543946 still recruiting?

NCT00543946 is currently completed. Last updated 25 September 2018.

Last reviewed 2018-09-25 · How we verify

NCT00543946

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Ascending Single Dose Study of The Safety, Tolerability, Pharmacokinetics, of GAP-134 Administered Intravenously as a 24-Hour Infusion to Healthy Japanese Male Subjects

Completed Phase 1 Last updated 25 September 2018

What this trial tests

Phase 1 trial testing GAP-134 in Arrhythmia in 56 participants. Completed in 1 March 2008.

Timeline

1 October 2007

Primary endpoint
1 March 2008

1 March 2008

Quick facts

Lead sponsor	Wyeth is now a wholly owned subsidiary of Pfizer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	single
Primary purpose	prevention
Enrollment	56
Start date	1 October 2007
Primary completion	1 March 2008
Estimated completion	1 March 2008
Sites	1 location across Japan

Drugs / interventions tested

GAP-134 — full drug profile →

Conditions studied

Arrhythmia — all drugs for Arrhythmia →

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer — full company profile →

Who can join

Adults 20 to 45, male only, with Arrhythmia. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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.
Time frame: 6 months

Sponsor's own description

This is a study of GAP-134, an antiarrhythmic di-peptide. This study will provide an initial assessment of the safety, tolerability, and pharmacokinetics (PK) of GAP-134 after administration of ascending single intravenous (IV) doses to healthy Japanese male subjects.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Cardiac to cancer: connecting connexins to clinical opportunity.
Grek CL, Rhett JM, Ghatnekar GS. · · 2014 · cited 39× · PMID 24607540 · DOI 10.1016/j.febslet.2014.02.047
Anti-arrhythmic strategies for atrial fibrillation: The role of computational modeling in discovery, development, and optimization.
Grandi E, Maleckar MM. · · 2016 · cited 26× · PMID 27612549 · DOI 10.1016/j.pharmthera.2016.09.012
New Strategies for the Treatment of Atrial Fibrillation.
Jost N, Christ T, Magyar J. · · 2021 · cited 5× · PMID 34577626 · DOI 10.3390/ph14090926

Verify or expand the search:

Other recruiting trials for Arrhythmia

Currently open trials in the same condition.

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NCT06984731 — The Safety and Efficacy of Radiofrequency Ablation After Left Atrial Appendage Occlusion. · recruiting
NCT06954103 — Mechanisms And Prognosis of Stroke-Heart Syndrome · recruiting

Other Wyeth is now a wholly owned subsidiary of Pfizer trials

Trials by the same sponsor.

NCT00909688 — Study to Evaluate Whether BLI-489 Can be Safely Tolerated by Healthy Subjects Given Multiple Doses · Phase 1 · completed
NCT00853749 — Immune Response In Children Revaccinated With Pneumococcal Conjugate Vaccine · Phase 3 · completed
NCT00894634 — Study Evaluating Brompheniramine Maleate Liquid in Children and Adolescents · Phase 1 · completed
NCT00854009 — Study Evaluating Single Doses of BLI-489 in Healthy Japanese Male Subjects · Phase 1 · completed
NCT00837837 — Study Evaluating Chlorpheniramine Maleate Liquid in Children and Adolescents · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00543946 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Wyeth is now a wholly owned subsidiary of Pfizer
Last refreshed: 25 September 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00543946.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing