A study to determine how the bodies of healthy study participants handle axelopran and oxycodone given as a combined tablet compared with given as separate tablets.

Phase 1

Completed

• Conditions: Opioid induced constipation; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

• Registration Number: ACTRN12614001152617
• Lead Sponsor: Theravance Biopharma R&D, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-31
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

healthy weight, BMI, medical history and on physical exam
- females must not be pregnant and males and females must practice approved contraception during the study
- screening lab assessments must have normal healthy results
- able to comply with study requirements and give informed consent

Exclusion Criteria

- history or evidence of severe allergic, or other disease as determined by the investigator to be of clinical significance
- history of chronic obstructive pulmonary disease, asthma or reactive airway disease
- history of, or current hypersensitivity to drugs
- any condition which may affect drug absorption
- recent participation in a trial of an investigational drug (or medical device) within 60 days (or 5 half-lives of the investigational drug, whichever is longer) prior to screening.
- Unwilling to abstain from caffeine products or alcohol or strenuous exercise beginning 24 hours prior to admission on Day -1 until the final PK sample is collected for each period.
- Consumption of grapefruit or grapefruit juice within 14 days prior to admission on Day -1.
- Consumption of other fruit juices within 24 hours prior to admission to the unit on Day -1 of any period.
- history of alcoholism or drug abuse
- history of tobacco use within previous 6 months
- Use of prescription or over-the-counter medications including herbals within 7 days (or14 days if the drug is a potent inducer or inhibitor of cytochrome P450 isoenzyme 3A4 or permeability glycoprotein 1, or five half-lives (whichever is longer) prior to Day -1 or requires continuous use during study participation, with the exception of routine vitamins or minerals, paracetamol (up to 1000 mg/day) if required, ibuprofen (up to 400 mg/day) if required, or ondansetron IV (up to 8 mg /day) if required.
- Blood donors within 8 weeks prior to screening
-abnormal ECG or family history of congenital long QT syndrome or family history of sudden death

Study & Design

• Study Type: Interventional
• Study Design: Not specified