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Trial · Interventional

CompletedPhase 1Registry data

Safety, Tolerability and Relative Bioavailability of Pegvisomant in Healthy Subjects

NCTNCT01181973 (opens ClinicalTrials.gov in a new tab)Other idA6291026
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Overview

Status
Completed
Phase
Phase 1
Enrollment
14 participants (actual)
Sponsor
Pfizer · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

Singapore

Start
Oct 2010
Primary completion
Jan 2011
Completion
Jan 2011
First posted
13 Aug 2010 (estimated)
Last update posted
5 Jan 2012 (estimated)
Conditions
Bioavailability

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201020112012
  1. Ph 1

    Safety, Tolerability and Relative Bioavailability of Pegvisomant in Healthy Subjects

    NCT01181973

    Oct 2010 to Jan 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • pegvisomantDrug
  • pegvisomantDrug
  • pegvisomantDrug
  • pegvisomantDrug

Arms2

  • Active comparator

    Treatment sequence #1

    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

  • Active comparator

    Treatment sequence #2

    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

Primary outcomes2

Outcomes the sponsor listed as primary.

  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(5)

  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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 21 Years up to 55 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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