An Open-Label Study to Evaluate the Single Dose Pharmacokinetic Profile and Safety of OROSĀ® Hydromorphone in Chinese Subjects With Cancer Who Are Not Opioid Tolerant
This is an open-label (all people know the identity of the intervention), single-dose study
in adult chinese participants with cancer. The study will consist of a screening phase
(within 21 to 1 days before admission to the research facility on Day -1) followed by a
4-day open-label treatment phase (Day -1 to Day 3). Participants will remain confined to the
study center from Day -1 until completion of the end-of-study visit or withdrawal
assessments, which will be done upon completion of the 48-hour pharmacokinetic sampling on
Day 3, or upon early withdrawal. The total study duration will be approximately 24 days. All
participants will undergo a naloxone challenge test (at a subcutaneous [under the skin] dose
of 0.8 milligram [mg]) for opioid dependency during the screening phase. Only those
participants who pass this challenge test will be allowed to continue in the study. During
the treatment phase, upon completion of a 10-hour overnight fast, participants will receive
a single oral (having to do with the mouth) 8 mg dose of hydromorphone in the morning of Day
1. Serial blood samples will be collected immediately before and through 48 hours after
dosing for the determination of plasma hydromorphone concentrations. Participants will be
administered naltrexone 50 mg, to block the opioid effects of hydromorphone, 14 hours
before, 2 hours before, and 10 hours after study drug administration. After the 10-hour
dose, additional doses of naltrexone will be administered every 12 hours up to 34 hours
postdose. Participants' safety will be monitored throughout the study.
Interventional
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Plasma Concentration (Cmax)
The Cmax is the maximum observed plasma concentration of study drug.
Pre-dose, 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48 hours post-dose
No
Xian-Janssen Pharmaceutical Ltd. Clinical Trial
Study Director
Xian-Janssen Pharmaceutical Ltd.
China: Food and Drug Administration
CR018070
NCT01824524
November 2011
August 2012
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