None listed
Conditions
Brief summary
The purpose of this study is to determine the pharmacokinetics (how the body absorbs the drug), safety, and tolerability of oxycodone and axelopran when given together and separately.
Interventions
The interventional product, axelopran 10mg, will be co-formulated with an oxycodone 20mg tablet and administered orally under fasting conditions. Both products will also be administered together but as separate tablets, and also as individual doses, so that study participants will each receive each of the 4 treatment options, separated by a week between dosing. In each Period, subjects will also receive co-treatment with naltrexone 50 mg orally (a single 50 mg dose 15 and 3 hours before and 9
The interventional product, axelopran 10mg, will be co-formulated with an oxycodone 20mg tablet and administered orally under fasting conditions. Both products will also be administered together but as separate tablets, and also as individual doses, so that study participants will each receive each of the 4 treatment options, separated by a week between dosing. In each Period, subjects will also receive co-treatment with naltrexone 50 mg orally (a single 50 mg dose 15 and 3 hours before and 9 and 21 hours after dosing with Study Treatment).
Sponsors
Theravance Biopharma R&D, Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Outcome results
None listed