NCT00959426

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, pharmacokinetics, and pharmacodynamics, of multiple oral doses of PF-04620110.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for phase_1 obesity

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

June 7, 2010

Status Verified

June 1, 2010

Enrollment Period

9 months

First QC Date

August 12, 2009

Last Update Submit

June 3, 2010

Conditions

ObesityOverweightHealthy

Keywords

- Mutliple Ascending Dose Study in Overweight Subjects - Body Weight - Signs and Symptoms

Outcome Measures

Primary Outcomes (3)

  • To assess safety and tolerability of PF-04620110 will be assessed by physical examinations, adverse event monitoring, 12-lead ECGs, vital sign, andc linical safety laboratory measurements.

    Baseline to 2 weeks

  • To characterize the PK of PF-04620110 following multiple oral doses in otherwise healthy overweight and obese subjects.

    Baseline to 2 weeks

  • To characterize the effect of PF-04620110 on postprandial lipid metabolism measures.

    Baseline to 2 weeks

Secondary Outcomes (6)

  • To examine additional pharmacodynamic markers in response to multiple oral doses of PF-04620110.

    Day -1 and Day 14

  • Secondary Pharmacodynamic Endpoints in response to a liquid meal test

    Day -1 and Day 14

  • Triglyceride excursions

    Day -1, Day 1, and Day 14

  • Glucose, insulin, and C-peptide excursions

    Day -1 and Day 14

  • Gut hormone excursions- including active GLP-1, total amide GLP-1, ghrelin, GIP, and PYY

    Day -1 and Day 14

  • +1 more secondary outcomes

Study Arms (2)

PF-04620110

EXPERIMENTAL
Drug: PF-04620110

Placebo Comparator

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PF-04620110DRUG

Multiple oral doses of PF-04620110 will be given. The specific dose will depend on the cohort to which the subject is assigned Initial planned doses are 1, 3, 5, 10 and 20 mg but may be modified based on emerging PK and safety data.

PF-04620110
PlaceboDRUG

Subjects will be given placebo or PF-04620110. Anticipated total daily doses for Cohorts A, B, C, D, E, F and G are 1, 3, 5, 10 and 20 mg. In each Cohort 9 subjects will receive active treatment and 3 will receive placebo for 14 days. Doses shown may be adjusted upwards or downwards and may be adjusted to include intermediate doses during the study based on ongoing safety, tolerability and PK results, but will not be projected to exceed established PK stopping criteria.

Placebo Comparator

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Publications (1)

  • Amin NB, Saxena AR, Somayaji V, Dullea R. Inhibition of Diacylglycerol Acyltransferase 2 Versus Diacylglycerol Acyltransferase 1: Potential Therapeutic Implications of Pharmacology. Clin Ther. 2023 Jan;45(1):55-70. doi: 10.1016/j.clinthera.2022.12.008. Epub 2023 Jan 21.

    PMID: 36690550DERIVED

Related Links

MeSH Terms

Conditions

ObesityOverweight

Interventions

PF-04620110

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 12, 2009

First Posted

August 14, 2009

Study Start

August 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

June 7, 2010

Record last verified: 2010-06

Locations

US(1)