A Multiple Dose Study Of PF-04971729 In Otherwise Healthy Overweight And Obese Volunteers

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01018823
First received: November 23, 2009
Last updated: March 25, 2010
Last verified: March 2010
  Purpose

PF-04971729 is under development for the treatment of Type 2 Diabetes. The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics, of multiple oral doses of PF-04971729.


Condition Intervention Phase
Obesity
Overweight
Drug: PF-04971729 or Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Phase 1, Randomized, Placebo-Controlled, Parallel Group, 14 Day Repeated Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-04971729 In Otherwise Healthy Overweight And Obese Adult Subjects

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety and tolerability endpoints evaluated by adverse event monitoring, laboratory values, cardiovascular monitoring [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic Endpoints: Single and Multiple-Dose PK for PF-04971729 and its metabolite PF-05217539. Urinary recovery will also be assessed for PF-04971729 and PF-05217539 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Pharmacodynamic Endpoints: 24-hour urinary glucose excretion, serum glucose and plasma c-peptide weighted mean over 24 hours, as well as inhibition of glucose reabsorption after single and 14-days of dosing along with body weight over time. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Exploratory Endpoints: Serum and urinary electrolyte measurements, serum intact parathyroid hormone (PTH) as measured by AUC(0-8), AUC(0-24) and trough as well as SGLT mRNA expression in sloughed renal cells. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: December 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 mg PF-04971729 or Placebo Drug: PF-04971729 or Placebo
PF-04971729 and placebo (4:1 ratio) oral dosing solutions/suspensions administered once daily for 14 days immediately after breakfast
Experimental: 5 mg PF-04971729 or Placebo
Planned dose: may be modified based on emerging PK and safety data.
Drug: PF-04971729 or Placebo
PF-04971729 and placebo (4:1 ratio) oral dosing solutions/suspensions administered once daily for 14 days immediately after breakfast
Experimental: PF-04971729 25mg or Placebo (4:1 ratio)
Planned dose: may be modified based on emerging PK and safety data.
Drug: PF-04971729 or Placebo
PF-04971729 and placebo (4:1 ratio) oral dosing solutions/suspensions administered once daily for 14 days immediately after breakfast
Experimental: PF-04971729 100mg or Placebo
Planned dose: may be modified based on emerging PK and safety data.
Drug: PF-04971729 or Placebo
PF-04971729 and placebo (4:1 ratio) oral dosing solutions/suspensions administered once daily for 14 days immediately after breakfast

Detailed Description:

To evaluate the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics, of multiple oral doses of PF-04971729.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.

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 disease (including drug allergies, but excluding untreated, asymptomatic,seasonal allergies at time of dosing).

Evidence of glycosuria, as defined by a positive urine dipstick test; Fasting (at least 10 hours) serum triglyceride >300 mg/dL; Fasting (at least 10 hours) LDL-cholesterol >190 mg/dL; Fasting (at least 10 hours) serum 25-OH Vitamin D concentration <20 ng/mL

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01018823

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01018823     History of Changes
Other Study ID Numbers: B1521002
Study First Received: November 23, 2009
Last Updated: March 25, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Healthy
Overweight
Obese Subjects

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014