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A Relative Bioavailability Study To Evaluate Safety, Tolerability And Pharmacokinetic Comparability Of Pegvisomant 1 X 30 Mg Vs 2 X 15 Mg Subcutaneously Administered In Healthy Subjects

NCT01893866 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2013-12-12

No results posted yet for this study

Summary

The primary purpose of this study is to evaluate pharmacokinetic comparability of 1x30 mg pegvisomant injection administered as a single 1 mL injection versus 2x15 mg/mL pegvisomant administered as two separate 1 mL injections and to characterize the pharmacokinetics of the new 30 mg strength.

Conditions

  • Healthy Volunteers

Interventions

DRUG

1 x 30 mg/mL pegvisomant

Subcutaneous injection, 30 mg, single dose.

DRUG

2 x 15 mg/mL pegvisomant

Subcutaneous injection, 2 injections of 15 mg, single dose.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Belgium

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01893866 on ClinicalTrials.gov