Safety, Tolerability and Relative Bioavailability of Pegvisomant in Healthy Subjects

Pfizer

Status and phase: Completed; Phase 1

Conditions: Bioavailability

Treatments: Drug: pegvisomant

Study type: Interventional

Funder types: Industry

Identifiers

NCT01181973

A6291026

Details and patient eligibility

About

The hypothesis to be tested is that the bioavailability of the new 30-mg vial is similar to that of the current approved 15 -mg vials. In addition, the SC injection using the new 30-mg vial is safe and well-tolerated.

Enrollment: 14 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy males or females between the ages of 21 and 55 years

Exclusion criteria

• Positive urine drug screen
• Excessive use of alcohol or nicotine-containing products
• Pregnant or nursing females

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Treatment sequence #1

Active Comparator group

Description:

One 1-mL subcutaneous injection at 30 mg/mL in Period 1 and two 1-mL subcutaneous injections at 15 mg/mL each in Period 2

Treatment:

Drug: pegvisomant

Drug: pegvisomant

Drug: pegvisomant

Drug: pegvisomant

Treatment sequence #2

Active Comparator group

Description:

Two 1-mL subcutaneous injections at 15 mg/mL each in Period 1 and one 1-mL SC injection at 30 mg/mL in Period 2

Treatment:

Drug: pegvisomant

Drug: pegvisomant

Drug: pegvisomant

Drug: pegvisomant