Pharmacokinetics and Bioavailability of Single Subcutaneous Doses of Methylnaltrexone Versus Intravenous Dose
An Open-Label, Phase I Study of the Pharmacokinetics and Bioavailability of Single, Ascending Subcutaneous Doses of Methylnaltrexone Versus Intravenous Dose in Normal, Healthy Male Volunteers
1 other identifier
interventional
6
1 country
1
Brief Summary
This is an open-label, Phase I study. Study treatments will entail a four-way crossover among three single, ascending, subcutaneous doses and one intravenous dose of MNTX in six healthy normal male volunteers. Blood samples will be obtained to determine plasma pharmacokinetics, dose proportionality for subcutaneous doses, and absolute bioavailability versus an intravenous dose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2002
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2002
CompletedFirst Submitted
Initial submission to the registry
May 27, 2011
CompletedFirst Posted
Study publicly available on registry
June 7, 2011
CompletedNovember 27, 2019
November 1, 2019
2 months
May 27, 2011
November 26, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Peak Plasma Concentration of MNTX
The objective of this study is to determine the plasma pharmacokinetic of single, ascending, subcutaneous doses and a single intravenous dose of methylnaltrexone (MNTX) in normal healthy male subjects.
32 days
Secondary Outcomes (7)
Time to Maximum Plasma Concentration (Tmax) of MNTX
32 days
Clearance of MNTX
32 days
Half-live of MNTX
32 days
Volume of Distribution of MNTX
32 days
Area Under the Plasma Concentration versus Time Curve (AUC) of MNTX
32 days
- +2 more secondary outcomes
Study Arms (4)
Arm 1
EXPERIMENTALArm 2
EXPERIMENTALArm 3
EXPERIMENTALArm 4
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Subject weight between 60 and 80 kg
- Subject a non-smoker
- Subject in good physical health, based on history, physical exam, appropriate laboratory and diagnostics tests at screening with no evidence of clinically significant chronic medical condition.
You may not qualify if:
- Subject with known hypersensitivity to methylnaltrexone, naltrexon or other opioids
- Subject consuming any prescription medication within the past two weeks, over-the-counter (OTC) products within seven days, any experimental medication within 30 days prior to study screening, or of any drug with a half-life longer then three days within 10 half-lives (\>30 days) of screening
- Subject consuming barbiturates or other inducers or inhibitors of CYP450 within 3 months of screening
- Subject with history or evidence of cardiovascular, gastrointestinal, hepatic, neurological, pulmonary, and renal or other significant chronic illness.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Progenics Pharmaceuticals, Inc.
Tarrytown, New York, 10591, United States
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Tage Ramakrishna, MD
Progenics Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 27, 2011
First Posted
June 7, 2011
Study Start
June 1, 2002
Primary Completion
August 1, 2002
Study Completion
August 1, 2002
Last Updated
November 27, 2019
Record last verified: 2019-11