A Study of PF-05175157 in Healthy Volunteers and Type 2 Diabetic Patients

NCT01396161 | Completed Phase 1 Results

• 1 other identifier: B1731007
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 3

Brief Summary

The primary purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of PF-05175157 in healthy volunteers and patients with type 2 diabetes mellitus.

Conditions

Diabetes Mellitus, Type 2

Keywords

Phase 1; Multiple Doses; Safety; Pharmacokinetics; Pharmacodynamics; Healthy Volunteers; Type 2 Diabetic Patients

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to PF-05175157 was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.

  2 weeks

Secondary Outcomes (7)

• Maximum Observed Plasma Concentration (Cmax)

  Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11

• Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)

  Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11

• Accumulation Ratio for Area Under the Concentration-Time Curve (Rˇac, AUC)

  Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11

• Renal Clearance (CLr)

  Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11

Study Arms (5)

30 mg PF-05175157 or Placebo QD

EXPERIMENTAL

Drug: PF-05175157 or Placebo

100 mg PF-05175157 or Placebo QD

EXPERIMENTAL

Planned dose might be modified based on emerging safety and PK data.

Drug: PF-05175157 or Placebo

200 mg PF-05175157 or Placebo QD

EXPERIMENTAL

Planned dose might be modified based on emerging safety and PK data.

Drug: PF-05175157 or Placebo

100 mg PF-05175157 or Placebo BID

EXPERIMENTAL

Planned dose might be modified based on emerging safety and PK data.

Drug: PF-05175157 or Placebo

xxx mg PF-05175157

EXPERIMENTAL

Dose will be determined based on results obtained from Arms 1 to 4.

Drug: PF-05175157 or Placebo

Interventions

PF-05175157 or Placebo DRUG

One oral dose of PF-05175157 or placebo is administered as a powder-in-capsule once daily for 14 days immediately before breakfast, in healthy volunteers.

30 mg PF-05175157 or Placebo QD

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and/or female 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.
• In addition, subjects must have normal pulmonary function tests and normal ocular examination.
• Body Mass Index (BMI) of 25.5 - 35.5 kg/m2; and a total body weight \>50 kg (110 lbs).
• Women must be of non-childbearing potential.
• Subjects with type 2 diabetes: HbA1c ≥7.0% and ≤10.0% if on metformin only, and ≥6.5% and ≤9.0% if patient requires to be washed-off an SU or DPP-4i.
• For subjects with type 2 diabetes, due to possible effects on disposition, CYP P450 3A4/5 and 2D6 substrates should not be co-administered with study medications.

You may not qualify if:

• Evidence or history of clinically significant hematological, renal, endocrine, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic seasonal allergies at time of dosing).
• Evidence or history of any chronic ongoing or current pulmonary disease.
• History of smoking in the past 5 years and a history of smoking more than 10 pack years, or history or evidence of habitual use of other (non smoked) tobacco or nicotine containing products within 3 months of Screening, or positive cotinine test at Screening or Day -3.
• Active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms or retinal/optic nerve disease.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (3)

Miami Research Associates

South Miami, Florida, 33143, United States

Location

MRA Clinical Research

South Miami, Florida, 33143, United States

Location

Pulmonary Physicians of South Florida

South Miami, Florida, 33143, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2011
• First Posted: July 18, 2011
• Study Start: July 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: November 7, 2016
• Results First Posted: November 7, 2016

Record last verified: 2016-09

Locations

US (3)