Pharmacokinetics and Bioavailability of Single Subcutaneous Doses of Methylnaltrexone Versus Intravenous Dose

NCT ID: NCT01367496

Last Updated: 2019-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-06-30
• Study Completion Date: 2002-08-31

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.

Conditions

Healthy Subjects

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

SC Methylnaltrexone (MNTX)

Intervention Type: DRUG

Dose 1

Arm 2

Group Type: EXPERIMENTAL

SC Methylnaltrexone (MNTX)

Intervention Type: DRUG

Dose 2

Arm 3

Group Type: EXPERIMENTAL

SC Methylnaltrexone (MNTX)

Intervention Type: DRUG

Dose 3

Arm 4

Group Type: EXPERIMENTAL

IV Methylnaltrexone (MNTX)

Intervention Type: DRUG

Interventions

SC Methylnaltrexone (MNTX)

Dose 1

Intervention Type: DRUG

SC Methylnaltrexone (MNTX)

Dose 2

Intervention Type: DRUG

SC Methylnaltrexone (MNTX)

Dose 3

Intervention Type: DRUG

IV Methylnaltrexone (MNTX)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Subject weight between 60 and 80 kg

2. Subject a non-smoker

3. 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.

Exclusion Criteria

1. Subject with known hypersensitivity to methylnaltrexone, naltrexon or other opioids

2. 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

3. Subject consuming barbiturates or other inducers or inhibitors of CYP450 within 3 months of screening

4. Subject with history or evidence of cardiovascular, gastrointestinal, hepatic, neurological, pulmonary, and renal or other significant chronic illness.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Progenics Pharmaceuticals, Inc.

Principal Investigators

Tage Ramakrishna, MD

Role: STUDY_DIRECTOR

Progenics Pharmaceuticals, Inc.

Locations

Progenics Pharmaceuticals, Inc.

Tarrytown, New York, United States

Countries

United States

Other Identifiers

MNTX 103

Identifier Type: -

Identifier Source: org_study_id