Trial · Interventional
CompletedPhase 1Registry dataA 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
Overview
- Status
- Completed
- Phase
- Phase 1
- Enrollment
- 17 participants (actual)
- Sponsor
- Pfizer · Industry
- Design
- Randomized · Open label (no masking)
- Countries
1 country
Belgium
- Start
- Aug 2013
- Primary completion
- Oct 2013
- Completion
- Oct 2013
- First posted
- 9 Jul 2013 (estimated)
- Last update posted
- 12 Dec 2013 (estimated)
- Conditions
- Healthy Volunteers
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 1
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
NCT01893866Aug 2013 to Oct 2013
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- 1 x 30 mg/mL pegvisomantDrug
- 2 x 15 mg/mL pegvisomantDrug
Arms2
Experimental
A
Experimental
B
Primary outcomes2
Outcomes the sponsor listed as primary.
AUCinf: Area under the concentration-time profile from time zero extrapolated to infinite time
Time frame · 4, 8, 12 (Day 1), 24, 30, 36 (Day 2), 48, 54, 60 (Day 3), 72, 78, 84 (Day 4), 120 (Day 6), 192 (Day 9), 264 (Day 12), 360 (Day 16) hours postdose
Registry description
Area under the concentration-time profile from time zero extrapolated to infinite time
AUClast: Area under the concentration-time profile from time zero to the time of the last quantifiable concentration (Clast)
Time frame · 4, 8, 12 (Day 1), 24, 30, 36 (Day 2), 48, 54, 60 (Day 3), 72, 78, 84 (Day 4), 120 (Day 6), 192 (Day 9), 264 (Day 12), 360 (Day 16) hours postdose
Registry description
Area under the concentration-time profile from time zero to the time of the last quantifiable concentration (Clast)
Secondary outcomes(3)
Cmax: Maximum concentration
Time frame · 4, 8, 12 (Day 1), 24, 30, 36 (Day 2), 48, 54, 60 (Day 3), 72, 78, 84 (Day 4), 120 (Day 6), 192 (Day 9), 264 (Day 12), 360 (Day 16) hours postdose
Registry description
Maximum concentration
Tmax: Time for Cmax
Time frame · 4, 8, 12 (Day 1), 24, 30, 36 (Day 2), 48, 54, 60 (Day 3), 72, 78, 84 (Day 4), 120 (Day 6), 192 (Day 9), 264 (Day 12), 360 (Day 16) hours postdose
Registry description
Time for Cmax
Half-life:Terminal elimination half-life
Time frame · 4, 8, 12 (Day 1), 24, 30, 36 (Day 2), 48, 54, 60 (Day 3), 72, 78, 84 (Day 4), 120 (Day 6), 192 (Day 9), 264 (Day 12), 360 (Day 16) hours postdose
Registry description
Terminal elimination half-life
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 18 Years up to 55 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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