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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01366326

Enrollment

Registered

2011-06-06

Start date

2010-07-31

Completion date

2010-08-31

Last updated

2019-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adult Subjects

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.

Interventions

DRUGMethylnaltrexone bromide

Subcutaneous MNTX

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

1. Body weight ≥40 kg (88 lb) 2. In good health with no clinically significant abnormal findings on the physical examination, medical history or the screening 12-lead ECG 3. Non-smoker 4. Has no known allergies to study drug or other related chemically-related compounds (i.e. naltrexone, naloxone).

Exclusion criteria

1. History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease 2. History of clinically significant allergies 3. Positive urine screen for drugs 4. History of positive blood screen for human immunodeficiency virus (HIV), hepatitis B virus (Hep B), or hepatitis C virus (HCV) 5. Prior exposure, allergy or known hypersensitivity to methylnaltrexone 6. Diagnosis of alcohol or substance dependence within the past 12 months.

Design outcomes

Primary

Measure	Time frame	Description
Peak Plasma Concentration (Cmax) of MNTX and its Metabolites	7 days	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.

Secondary

Measure	Time frame	Description
Peak Time of Maximum Concentration (Tmax) of MNTX and its Metabolites	7 Days	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.
Area Under the Plasma Concentration versus Time Curve (AUC) of MNTX and its Metabolites.	7 Days	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026