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OpenTrials
Completed

NCT Number: NCT01181973

Safety, Tolerability and Relative Bioavailability of Pegvisomant in Healthy Subjects

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.

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Key information

Conditions

Bioavailability

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Singapore, 188770

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Pegvisomant

Drug

One 1-mL subcutaneous injection at 30 mg/mL. A 30-mg vial is supplied as lyophilized powder. Each vial should be reconstituted with 1 mL of Sterile Water for Injection (WFI).

Other names: B2036-PEG

Primary outcomes

  1. The area under the pegvisomant concentration-time curve from time 0 to infinity hours post dose (AUCinf)

    Time frame: 16 days

  2. The area under the pegvisomant concentration-time curve from time 0 to last observed timepoint (AUClast)

    Time frame: 16 days

Secondary outcomes

  1. Maximal pegvisomant concentration (Cmax)

    Time frame: 16 days

  2. The timepoint at which Cmax is obtained (Tmax)

    Time frame: 16 days

  3. Elimination half-life of pegvisomant (as data permit)

    Time frame: 16 days

  4. Biomarkers IGF-1 (A few samples will be taken at timepoints around Tmax to observe the pegvisomant effect on IGF-1)

    Time frame: 16 days

  5. Safety laboratory tests (including hematology and serum chemistry parameters) and adverse events (including local site reactions)

    Time frame: 16 days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

An Open-label, Randomized, Phase 1, Single-Dose Crossover Study to Evaluate Safety, Tolerability and Relative Bioavailability of Pegvisomant 1 X 30 Mg Vs 2 X 15 Mg Subcutaneously Administered in Healthy Subjects

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 13, 2010
Registry last updated
Jan 5, 2012

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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