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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
History of Changes

November 23, 2010
July 5, 2011
December 2010
June 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01247896 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Single Dose Escalation Study of PF-05190457 in Healthy Volunteers
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

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type II
  • 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
  • Drug: Placebo
    Single Dose Placebo
  • Experimental: Active
    Interventions:
    • Drug: PF-05190457
    • Drug: PF-05190457
    • Drug: PF-05190457
    • Drug: PF-05190457
    • Drug: PF-05190457
    • Drug: PF-05190457
    • Drug: PF-05190457
    • Drug: PF-05190457
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01247896
B3301001
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP