Single Dose Study Of PF-04308515 And Prednisone On Carbohydrate

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PF-04308515; Drug: Prednisone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01199029

B0861004

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 7 patient groups

(Part 1) 10 mg PF-04308515 (8hrs)

Experimental group

Treatment:

Drug: PF-04308515

Drug: PF-04308515

Drug: PF-04308515

Drug: PF-04308515

(Part 1) 10 mg PF-04308515 (12hrs)

Experimental group

Treatment:

Drug: PF-04308515

Drug: PF-04308515

Drug: PF-04308515

Drug: PF-04308515

(Part 1) 5 mg Prednisone

Active Comparator group

Treatment:

Drug: Prednisone

Drug: Prednisone

Drug: Prednisone

(Part 2) X mg PF-04308515

Experimental group

Treatment:

Drug: PF-04308515

Drug: PF-04308515

Drug: PF-04308515

Drug: PF-04308515

(Part 2) Y mg PF-04308515

Experimental group

Treatment:

Drug: PF-04308515

Drug: PF-04308515

Drug: PF-04308515

Drug: PF-04308515

(Part 2) 5 mg Prednisone

Active Comparator group

Treatment:

Drug: Prednisone

Drug: Prednisone

Drug: Prednisone

(Part 2) 20 mg Prednisone

Active Comparator group

Treatment:

Drug: Prednisone

Drug: Prednisone

Drug: Prednisone