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Completed

NCT Number: NCT01199029

Single Dose Study Of PF-04308515 And Prednisone On Carbohydrate

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Kalamazoo, Michigan, 49007, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PF-04308515

Drug

10 mg extemporaneous preparation of oral solution predosed 8 hours prior to Oral Glucose Tolerance Test(OGTT)

Prednisone

Drug

5 mg tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)

Primary outcomes

  1. Fold change in AUC (0-4hr) relative to no treatment baseline for plasma glucose, plasma insulin and plasma C-peptide

    Time frame: 4 hours

Secondary outcomes

  1. Pharmacodynamic effects on plasma glucose, plasma insulin, and plasma C-peptide

    Time frame: 3 days

  2. Safety: adverse events, vital sign measurements, physical examination

    Time frame: 3 days

  3. Pharmacokinetics: sparse PF-04308515 plasma samples will be collected

    Time frame: 3 days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 10, 2010
Registry last updated
Dec 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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