Single Dose Study Of PF-04308515 And Prednisone On Carbohydrate

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01199029
First received: September 9, 2010
Last updated: December 15, 2010
Last verified: December 2010
  Purpose

This study will investigate the effect of a single dose of PF-04308515 or prednisone on calculated measures of glucose tolerance and insulin resistance by using a modified oral glucose tolerance test.


Condition Intervention Phase
Healthy
Drug: PF-04308515
Drug: Prednisone
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Study Evaluating The Effect Of Single Doses Of Pf-04308515 And Prednisone On Carbohydrate Metabolism Utilizing An Oral Glucose Tolerance Test In Healthy Adult Subjects

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Fold change in AUC (0-4hr) relative to no treatment baseline for plasma glucose, plasma insulin and plasma C-peptide [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacodynamic effects on plasma glucose, plasma insulin, and plasma C-peptide [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Safety: adverse events, vital sign measurements, physical examination [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics: sparse PF-04308515 plasma samples will be collected [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: August 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: (Part 1) 10 mg PF-04308515 (8hrs) Drug: PF-04308515
10 mg extemporaneous preparation of oral solution predosed 8 hours prior to Oral Glucose Tolerance Test(OGTT)
Experimental: (Part 1) 10 mg PF-04308515 (12hrs) Drug: PF-04308515
10 mg extemporaneous preparation of oral solution predosed 12 hours prior to Oral Glucose Tolerance Test(OGTT)
Active Comparator: (Part 1) 5 mg Prednisone Drug: Prednisone
5 mg tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)
Experimental: (Part 2) X mg PF-04308515 Drug: PF-04308515
X mg of Pf-04308515 extemporaneous oral solution predosed at selected time from Part 1 prior to Oral Glucose Tolerance Test (OGTT)
Experimental: (Part 2) Y mg PF-04308515 Drug: PF-04308515
Y mg of Pf-04308515 extemporaneous oral solution predosed at selected time from Part 1 prior to Oral Glucose Tolerance Test (OGTT)
Active Comparator: (Part 2) 5 mg Prednisone Drug: Prednisone
5 mg tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)
Active Comparator: (Part 2) 20 mg Prednisone Drug: Prednisone
20 mg (5 mg tablets) predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)

  Eligibility

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

Inclusion Criteria:

  • BMI 17.5 to 30.5 kg/m2 and total body weight >50 kg

Exclusion Criteria:

  • Fasting glucose above the limits of the reference range for healthy individuals
  • "No treatment" OGTT indicative of impaired fasting glucose or impaired glucose tolerance
  • Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation
  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: NCT01199029

Locations
United States, Michigan
Pfizer Investigational Site
Kalamazoo, Michigan, United States, 49007
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: NCT01199029     History of Changes
Other Study ID Numbers: B0861004
Study First Received: September 9, 2010
Last Updated: December 15, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Healthy People
Glucocorticoids
Prednisone

Additional relevant MeSH terms:
Prednisone
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 28, 2014