A Single Dose Study Of PF-05161704 In Healthy Volunteers

A Phase 1 Placebo-Controlled Study To Assess The Safety, Tolerability And Pharmacokinetics Of PF-05161704 After Administration Of Single Escalating Oral Doses Under Fed And Fasted Conditions In Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01183715

Enrollment

Registered

2010-08-18

Start date

2010-07-31

Completion date

2010-09-30

Last updated

2019-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Single Ascending Dose, Phase 1, Safety and Tolerability, PK, Healthy Subjects

Brief summary

The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single oral doses of PF-05161704 in healthy volunteers.

Interventions

DRUGPF-05161704 or placebo

PF-05161704 will be administered as an extemporaneously prepared suspension in the initially planned dose range of 1.5 mg to 300 mg. Correspondingly, placebo doses will be administered as suspension

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male and/or female (non child-bearing potential) subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests). * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * Any condition possibly affecting drug absorption (eg, gastrectomy). * History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening. * History or evidence of habitual use of tobacco or nicotine containing products within 3 months of Screening or positive cotinine test at screening or Day 0 of period one

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of escalating single oral doses of PF-05161704 in healthy subjects	1 month
Single dose pharmacokinetics of PF-05161704 and its metabolite PF-05200145	1 month

Secondary

Measure	Time frame
Preliminary pharmacodynamics of PF-05161704	1 month

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026