NCT01369836 is a Phase 1 clinical trial of Tafamidis meglumin in Healthy, sponsored by Pfizer.

Who is sponsoring NCT01369836?

NCT01369836 is sponsored by Pfizer.

What drugs are being tested in NCT01369836?

Interventions in NCT01369836: Tafamidis meglumin, Tafamidis meglumin, Placebo.

Is NCT01369836 still recruiting?

NCT01369836 is currently completed. Last updated 12 September 2011.

Last reviewed 2011-09-12 · How we verify

NCT01369836

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

An Investigator And Subject-Blind Phase 1 Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-06291826 (Tafamidis) After Single Oral Administration To Japanese And Western Healthy Subjects

Completed Phase 1 Last updated 12 September 2011

What this trial tests

Phase 1 trial testing Tafamidis meglumin in Healthy in 21 participants. Completed in 1 August 2011.

Timeline

1 July 2011

Primary endpoint
1 August 2011

1 August 2011

Quick facts

Lead sponsor	Pfizer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	basic science
Enrollment	21
Start date	1 July 2011
Primary completion	1 August 2011
Estimated completion	1 August 2011
Sites	1 location across United States

Drugs / interventions tested

Tafamidis meglumin — full drug profile →
Tafamidis meglumin — full drug profile →
Placebo

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Pfizer — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy. Healthy volunteers can join.

What's being measured

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

Plasma concentration of tafamidis over time (AUClast).
Time frame: 2 months
Plasma concentration of tafamidis over time (Cmax).
Time frame: 2 months
Plasma concentration of tafamidis over time (Tmax).
Time frame: 2 months
If data permit, AUCinf and t1/2 will be determined.
Time frame: 2 months

Sponsor's own description

The purpose of this study is the following: * To evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered tafamidis in Japanese and Western healthy volunteers at single dose. * To compare Japanese and Western PK profiles. * Determine the PD stabilization effect of tafamidis on human transthyretin (TTR) in a validated ex vivo assay.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Other Pfizer trials

Trials by the same sponsor.

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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 NCT01369836 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 12 September 2011

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/NCT01369836.

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