A Study to Assess How the Body Processes a Strong Painkiller When it is Given Alongside a Drug That Counteracts the Side Effects of Strong Painkillers in a Fasted and Fed State.
A 4-part, Single-dose, Open-label, Randomised, Crossover, Exploratory Study in Healthy Subjects to Assess the Influence of an Opioid Antagonist on How the Body Processes a Strong Painkiller, When Co-administered in a Fasted and Fed State.
2 other identifiers
interventional
16
1 country
1
Brief Summary
To assess whether an opioid antagonist has any impact on the release of a strong painkiller in the blood when it is given to healthy volunteers when they have eaten and also when they have fasted.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 pain
Started Apr 2014
Shorter than P25 for phase_1 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2014
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedFirst Posted
Study publicly available on registry
May 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedJune 27, 2014
June 1, 2014
2 months
February 25, 2014
June 26, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacokinetics parameters AUC and Cmax
Up to 32 hours
Secondary Outcomes (4)
Adverse Events
7 to 10 days
Vital Signs
0 to 32 hours
Clinical Laboratory Tests
Day 0 and Day 7-10
ECG
Screening, 1 our post-dose and Day 7-10
Study Arms (4)
12 hourly capsule fasted
ACTIVE COMPARATOR4 mg 12 hourly capsule - strong pain killer fasted
12 hourly capsule fed
ACTIVE COMPARATOR4 mg 12 hourly capsule - strong pain killer fed
12 hourly capsule with antagonist fasted
EXPERIMENTAL4 mg 12 hourly capsule strong painkiller with antagonist fasted
12 hourly capsule with antagonist fed
EXPERIMENTAL4 mg 12 hourly capsule strong painkiller with antagonist fed
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (1)
Quotient Clinical Limited
Nottingham, Nottinghamshire, NG11 6JS, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2014
First Posted
May 8, 2014
Study Start
April 1, 2014
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
June 27, 2014
Record last verified: 2014-06