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Single Dose Escalation Study of PF-05190457 in Healthy Volunteers

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT01247896
Collaborator
(none)
26
Enrollment
1
Location
2
Arms
6
Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, 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
Study Start Date :
Dec 1, 2010
Actual Primary Completion Date :
Jun 1, 2011
Actual Study Completion Date :
Jun 1, 2011

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. 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 [8 weeks]

  2. 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 [48 hour]

Secondary Outcome Measures

  1. 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), [48 hour]

  2. Gastric half-emptying time (GET½), the duration of the lag phase (Tlag), gastric emptying coefficient (GEC) [Day 1 for Periods 1 and 2, for Cohort 3.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Bruxelles Belgium B-1070

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01247896
Other Study ID Numbers:
  • B3301001
First Posted:
Nov 24, 2010
Last Update Posted:
Jul 6, 2011
Last Verified:
Jul 1, 2011
Additional relevant MeSH terms:
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jul 6, 2011