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Completed

NCT Number: NCT01366326

Evaluate the Pharmacokinetics (PK) of Methylnaltrexone (MNTX) in Healthy Adult Subjects

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.

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Key information

Conditions

Healthy Adult Subjects

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Progenics Pharmaceuticals, Inc.

Tarrytown, New York, 10591, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Methylnaltrexone bromide

Drug

Subcutaneous MNTX

Primary outcomes

  1. Peak Plasma Concentration (Cmax) of MNTX and its Metabolites

    Time frame: 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 outcomes

  1. Peak Time of Maximum Concentration (Tmax) of MNTX and its Metabolites

    Time frame: 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.

  2. Area Under the Plasma Concentration versus Time Curve (AUC) of MNTX and its Metabolites.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Registry information

Official study title

A Multiple-Dose, Open-Label Study to Evaluate the Pharmacokinetics of MNTX in Healthy Adult Subjects

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 6, 2011
Registry last updated
Nov 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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