Safety, Tolerability and Relative Bioavailability of Pegvisomant in Healthy Subjects
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ClinicalTrials.gov Identifier: NCT01181973 |
Recruitment Status :
Completed
First Posted : August 13, 2010
Last Update Posted : January 5, 2012
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Condition or disease | Intervention/treatment | Phase |
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Bioavailability | Drug: pegvisomant | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 14 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official 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 |
Study Start Date : | October 2010 |
Actual Primary Completion Date : | January 2011 |
Actual Study Completion Date : | January 2011 |

Arm | Intervention/treatment |
---|---|
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
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Drug: pegvisomant
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 Name: B2036-PEG Drug: pegvisomant Two 1-mL subcutaneous injections at 15 mg/mL each. Two 15-mg vials are supplied as lyophilized powder. Each vial should be reconstituted with 1 mL of Sterile Water for Injection (WFI).
Other Name: B2036-PEG |
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
|
Drug: pegvisomant
Two 1-mL subcutaneous injections at 15 mg/mL each. Two 15-mg vials are supplied as lyophilized powder. Each vial should be reconstituted with 1 mL of Sterile Water for Injection (WFI).
Other Name: B2036-PEG Drug: pegvisomant 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 Name: B2036-PEG |
- The area under the pegvisomant concentration-time curve from time 0 to infinity hours post dose (AUCinf) [ Time Frame: 16 days ]
- The area under the pegvisomant concentration-time curve from time 0 to last observed timepoint (AUClast) [ Time Frame: 16 days ]
- Maximal pegvisomant concentration (Cmax) [ Time Frame: 16 days ]
- The timepoint at which Cmax is obtained (Tmax) [ Time Frame: 16 days ]
- Elimination half-life of pegvisomant (as data permit) [ Time Frame: 16 days ]
- 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 ]
- Safety laboratory tests (including hematology and serum chemistry parameters) and adverse events (including local site reactions) [ Time Frame: 16 days ]

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Ages Eligible for Study: | 21 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01181973
Singapore | |
Pfizer Investigational Site | |
Singapore, Singapore, 188770 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT01181973 |
Other Study ID Numbers: |
A6291026 |
First Posted: | August 13, 2010 Key Record Dates |
Last Update Posted: | January 5, 2012 |
Last Verified: | January 2012 |
Relative bioavailability pegvisomant |