NCT01369277 is a Phase 1 clinical trial of PF-04991532 in Diabetes Mellitus, sponsored by Pfizer.

Who is sponsoring NCT01369277?

NCT01369277 is sponsored by Pfizer.

What drugs are being tested in NCT01369277?

Interventions in NCT01369277: PF-04991532, Placebo, PF-04991532.

What condition does NCT01369277 study?

NCT01369277 studies Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders.

Is NCT01369277 still recruiting?

NCT01369277 is currently completed. Last updated 20 September 2011.

Last reviewed 2011-09-20 · How we verify

NCT01369277

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

A Phase 1, Randomized, Double Blind, Placebo-Controlled, Single Dose Escalation Study In Japanese Healthy Subjects, And Open Label, Single Dose Study In Western Healthy Subjects To Investigate The Safety, Tolerability, And Pharmacokinetics of PF-04991532.

Completed Phase 1 Last updated 20 September 2011

What this trial tests

Phase 1 trial testing PF-04991532 in Diabetes Mellitus in 22 participants. Completed in 1 September 2011.

Timeline

1 June 2011

Primary endpoint
1 September 2011

1 September 2011

Quick facts

Lead sponsor	Pfizer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Enrollment	22
Start date	1 June 2011
Primary completion	1 September 2011
Estimated completion	1 September 2011
Sites	1 location across United States

Drugs / interventions tested

PF-04991532 — full drug profile →
Placebo
PF-04991532 — full drug profile →

Conditions studied

Diabetes Mellitus — all drugs for Diabetes Mellitus →
Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
Glucose Metabolism Disorders — all drugs for Glucose Metabolism Disorders →

Sponsor

Pfizer — full company profile →

Who can join

Adults 18 to 55, any sex, with Diabetes Mellitus or Diabetes Mellitus, Type 2. Healthy volunteers can join.

What's being measured

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

Maximum Plasma Concentration (Cmax)
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10,12 and 16, 24, 36 and 48 hours post dose
Time for Cmax (Tmax)
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10,12 and 16, 24, 36 and 48 hours
Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast)
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10,12 and 16, 24, 36 and 48 hours
Area under the plasma concentration-time profile from time zero to 24 hours (AUC0-24)
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10,12 and 16, 24, 36 and 48 hours
Total amount of unchanged drug excreted in the urine over 24 hours, expressed as percent of dose (Ae24%)
Time frame: Urine collection from 0 to 24 hours post dose
Renal clearance (CLr)
Time frame: Urine collection from 0 to 24 hours post dose

Sponsor's own description

This study is to investigate the safety, tolerability and pharmacokinetics of single ascending oral doses of PF-04991532 in Japanese healthy subjects. The secondary objective is to investigate the pharmacokinetics and safety of single ascending oral doses of PF-04991532 in Western healthy subjects and to compare the pharmacokinetics between Japanese and Western healthy subjects.

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:

Other recruiting trials for Diabetes Mellitus

Currently open trials in the same condition.

NCT07238556 — A Novel Digital Tool Physicians Can Use to Prescribe Exercise to Patients With Cardiovascular Disease Risk Factors · NA · recruiting
NCT07392437 — Prevalence of Diabetes-related Distress Among Patients Living With Type 2 Diabetes in a University Hospital Center and I · NA · recruiting
NCT07448805 — Accuracy and Safety of the Syai Tag System for Continuous Glucose Monitoring in Intensive Internal Care Unit · NA · recruiting
NCT07425275 — Integrated Oral Care Intervention for Xerostomia in Diabetes Patients · NA · recruiting
NCT06918977 — Improving Glycemic Control With Telemedicine and Smart Insulin Pens · NA · recruiting

Other Pfizer trials

Trials by the same sponsor.

NCT04982848 — Korea Post Marketing Surveillance (PMS) Study of Talzenna® · not yet recruiting
NCT06873191 — A Study to Learn More About Tukysa Once it is Out in the Korean Market · not yet recruiting
NCT07497854 — A Study to Learn About the Study Medicine NURTEC® ODT 75 mg After it is Released Into the Markets in Korea · not yet recruiting
NCT06507904 — A Study to Learn How Different Preparations of Osivelotor Taste and Enter the Blood With Food or Liquids or With an Anta · Phase 1 · not yet recruiting
NCT06864585 — A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan · not yet recruiting

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 NCT01369277 (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: 20 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/NCT01369277.

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