Evaluate the Pharmacokinetics (PK) of Methylnaltrexone (MNTX) in Healthy Adult Subjects
A Multiple-Dose, Open-Label Study to Evaluate the Pharmacokinetics of MNTX in Healthy Adult Subjects
1 other identifier
interventional
20
1 country
1
Brief Summary
MNTX 1109 is a single center, open label study, composed of normal healthy adult subjects to evaluate the PK of MNTX and its metabolites administered once daily as a subcutaneous (SC) injection for a period of seven days. Blood samples will be obtained at screening and for drug concentration data.
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 Jul 2010
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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 27, 2011
CompletedFirst Posted
Study publicly available on registry
June 6, 2011
CompletedNovember 29, 2019
November 1, 2019
1 month
May 27, 2011
November 26, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Peak Plasma Concentration (Cmax) of MNTX and its Metabolites
To evaluate the PK profile of MNTX and its metabolites when administered as a SC injection once daily for seven days in healthy adult subjects.
7 days
Secondary Outcomes (2)
Peak Time of Maximum Concentration (Tmax) of MNTX and its Metabolites
7 Days
Area Under the Plasma Concentration versus Time Curve (AUC) of MNTX and its Metabolites.
7 Days
Study Arms (1)
Arm 1
EXPERIMENTALMethylnaltrexone bromide
Interventions
Eligibility Criteria
You may qualify if:
- Body weight ≥40 kg (88 lb)
- In good health with no clinically significant abnormal findings on the physical examination, medical history or the screening 12-lead ECG
- Non-smoker
- Has no known allergies to study drug or other related chemically-related compounds (i.e. naltrexone, naloxone).
You may not qualify if:
- History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease
- History of clinically significant allergies
- Positive urine screen for drugs
- History of positive blood screen for human immunodeficiency virus (HIV), hepatitis B virus (Hep B), or hepatitis C virus (HCV)
- Prior exposure, allergy or known hypersensitivity to methylnaltrexone
- Diagnosis of alcohol or substance dependence within the past 12 months.
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
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2011
First Posted
June 6, 2011
Study Start
July 1, 2010
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
November 29, 2019
Record last verified: 2019-11