A Pharmacokinetic and Safety Study of Osmotic Release Oral System (OROS) Hydromorphone in Non-Opioid Tolerant Chinese Participants With Cancer

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the single dose pharmacokinetic profile (explores what a drug does to the body) and safety of Osmotic Release Oral System (OROS) hydromorphone in chinese participants with cancer (abnormal tissue that grows and spreads in the body) who are not opioid (morphine-like medications) tolerant (decrease in response to a fixed dosage of drug over time and higher doses of a drug are needed to get desired effect).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xian-Janssen Pharmaceutical Ltd.
• Treatments: Hydromorphone

Criteria

Inclusion Criteria:

• Participants diagnosed with early stage cancer, with no active metastases (spread of cancer cells from one part of the body to another), or severe intercurrent systemic disease. No extensive radiotherapy (treatment of cancer using x-rays), systemic biologic or cytotoxic therapy within 4 weeks before the first dose of study drug. Immunotherapy (giving of drugs to help the body's immune [protective] system; usually used to destroy cancer cells) or hormone therapy with stable dose would still be allowed

• Participants who are not opioid (morphine-like medications) tolerant: no previous use of an opioid or no use of an opioid within 21 days before the first dose of study drug on Day 1

• Participants who previously have received opioid medication for pain management will have had their opioid medication discontinued for reasons unrelated to this study

• Women must be postmenopausal (no spontaneous menses for at least 2 years), surgically sterile, abstinent (not having sexual intercourse), or, if sexually active, be practicing an effective method of birth control before entry, throughout the study and up to 15 days after the end of the study/early withdrawal

• Men must agree to use an adequate contraception method (example, vasectomy [surgery to cut out part or all of the ductus deferens to make a man not able to produce children], double-barrier [using two forms of effective contraception (example, condom and spermicide)], partner using effective contraception) and to not donate sperm during the study and for up to 1 month after the end of the study or early withdrawal

• Signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

• Participants with a history of cardiac, nervous system or respiratory disease which in the investigator's judgment precluded participation in the study because of the potential for respiratory depression

• Participants with gastrointestinal disease of sufficient severity (very serious, life threatening) to be likely to interfere with oral analgesia (drug used to control pain) including: dysphagia (trouble swallowing), vomiting, no bowel (the intestine) movement or bowel obstruction (block, blockage) due to impaction within 5 days of the study, severe gut narrowing that may affect the absorption (the way a drug or other substance enters the body) of orally administered drugs, particularly the insoluble hydromorphone outer coating

• Participants who are unable to swallow solid, oral dosage forms whole with the aid of water

• Use of monoamine oxidase inhibitors (MAO-I) within 21 days before the first dose of study drug on Day 1

• Use of opioids within 21 days before the first dose of study drug on Day 1