Pharmacokinetics and Bioavailability Comparison of Two Different Formulations of MNTX Tablets
1 other identifier
interventional
24
1 country
1
Brief Summary
This was a single-center, double-blind, randomized, cross-over Phase 1 study in normal, healthy volunteers. Study treatment entailed single doses of two different formulations of MNTX tablets.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 2004
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
February 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
May 27, 2011
CompletedFirst Posted
Study publicly available on registry
June 6, 2011
CompletedNovember 27, 2019
November 1, 2019
29 days
May 27, 2011
November 26, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Peak plasma concentration (Cmax) of MNTX administered as two different oral formulations
To determine and compare the plasma pharmacokinetics and extent of single, oral doses of two different oral formulations of MNTX in normal healthy volunteers.
7 days
Secondary Outcomes (5)
Half-life of MNTX administered as two different oral formulations
7 days
Time from a single dose to maximum concentration (Tmax) of MNTX administered as two different oral formulations
7 days
Area under the plasma concentration (AUC) of MNTX administered as two different oral formulations
7 days
Total body clearance over bioavailability (CL/F) of MNTX administered as two different oral formulations
7 days
Volume of distribution over bioavailability (V/F) of MNTX administered as two different oral formulations
7 days
Study Arms (2)
Arm 1
EXPERIMENTALMNTX tablet
Arm 2
EXPERIMENTALMNTX tablet
Interventions
Eligibility Criteria
You may qualify if:
- Weight between 55 and 85 kg
- In good health, based on history, physical examination, and appropriate laboratory and diagnostic tests at screening, with no evidence of clinically significant chronic medical condition
- Non-smokers.
You may not qualify if:
- History of evidence of cardiovascular, gastrointestinal, hepatic, musculoskeletal, neurological, pulmonary, renal, or other significant chronic illness
- History of asthma, allergic skin rash, significant allergy, or other immunologic disorder
- Consumption of barbiturates or other inducers or inhibitors of CYP450
- History or suspicion of alcohol or drug abuse.
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
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 27, 2011
First Posted
June 6, 2011
Study Start
February 1, 2004
Primary Completion
March 1, 2004
Study Completion
March 1, 2004
Last Updated
November 27, 2019
Record last verified: 2019-11