A Multiple Dose Study Of PF-04620110 In Healthy Overweight Or Obese Subjects

A Phase 1, Parallel, Randomized Trial To Assess The Effect Of Time Of Dosing On The Pharmacodynamics, Pharmacokinetics, Safety And Tolerability Of Multiple Oral Doses Of PF-04620110 In Otherwise Healthy Overweight Or Obese Adult Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01146327

Enrollment

Registered

2010-06-17

Start date

2010-06-30

Completion date

2011-01-31

Last updated

2011-04-19

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

Conditions

Healthy

Keywords

Multiple Dose Study in Overweight Healthy Subjects, body weight

Brief summary

PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this trial is to evaluate the safety and tolerability, and pharmacodynamics, of multiple oral doses of PF-04620110.

Interventions

DRUGPF-04620110

Multiple oral doses of 5 mg of PF-04620110 will be given once daily for 2 weeks.

DRUGPlacebo

Multiple oral doses of placebo will be given once daily for 2 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male and/or female subjects between the ages of 18 and 55 years * Body Mass Index (BMI) of 26.5 to 35.5 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 (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening.

Design outcomes

Primary

Measure	Time frame
To evaluate secondary Pharmacodynamic Endpoints in response to a liquid meal test in response to multiple oral doses of PF-04620110.	Day 6 and Day 14
To evaluate additional pharmacodynamic markers in response to multiple oral doses of PF-04620110.	Day 1 to Day 13

Secondary

Measure	Time frame
To characterize the PK of PF-04620110 following multiple oral doses in otherwise healthy overweight and obese subjects.	Baseline to 2 weeks
To assess safety and tolerability of PF-04620110 will be assessed by physical examinations, adverse event monitoring, 12-lead ECGs, vital sign, and clinical safety laboratory measurements.	Baseline to 2 weeks

Countries

Belgium, Singapore

Outcome results

None listed

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