Single Dose Escalation Study of PF-05190457 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01247896
First received: November 23, 2010
Last updated: July 5, 2011
Last verified: July 2011
  Purpose

PF-05190457 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The purpose of the study is to evaluate the safety and tolerability of PF-05190457 after administration of a single dose to healthy volunteers and to evaluate the plasma drug concentrations after single dose in healthy volunteers.


Condition Intervention Phase
Diabetes Mellitus, Type II
Drug: PF-05190457
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1 Placebo-controlled Trial to Assess the Safety, Tolerability, and Pharmacokinetics of Single Escalating Oral Doses of PF-05190457 Under Fasted and Fed Conditions in Healthy Adult Subjects

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety and tolerability of PF-05190457 will be assessed by physical examinations, adverse event monitoring, 12-lead ECGs, continuous cardiac monitoring over the first 8 hours after dosing, vital sign and clinical safety laboratory measurements [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • The single dose PK of PF-05190457 will be described by estimating parameters of AUC(0-infinity), AUC(0-last), AUC(0-24), Cmax, Tmax, CL/F, Vz/F and half-life (t1/2), as the data permit [ Time Frame: 48 hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PK of PF-05190457 in the fed condition will be described by estimating parameters of AUC(0-infinity), AUC(0-last), AUC(0-24), Cmax, Tmax, CL/F, Vz/F and half-life (t1/2), [ Time Frame: 48 hour ] [ Designated as safety issue: No ]
  • Gastric half-emptying time (GET½), the duration of the lag phase (Tlag), gastric emptying coefficient (GEC) [ Time Frame: Day 1 for Periods 1 and 2, for Cohort 3. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 26
Study Start Date: December 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Drug: PF-05190457
Single Dose 2 mg
Drug: PF-05190457
Single Dose 10 mg
Drug: PF-05190457
Single Dose 30 mg
Drug: PF-05190457
Single Dose 100 mg
Drug: PF-05190457
Single Dose 300 mg
Drug: PF-05190457
Single Dose 600 mg
Drug: PF-05190457
Single Dose - to be determined with food
Drug: PF-05190457
Single Dose - to be determined
Placebo Comparator: Placebo Drug: Placebo
Single Dose Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males and females (non-childbearing) between the ages of 18 and 55 with BMI of 17.5 to 30.5 kg/m2; and a total body weight between 50 kg (110 lbs) and 100 kg (220 lb) inclusive

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01247896

Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, B-1070
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01247896     History of Changes
Other Study ID Numbers: B3301001
Study First Received: November 23, 2010
Last Updated: July 5, 2011
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 15, 2014