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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

Phase 1
18 Years
65 Years
Not Enrolling

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Trial Information

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.

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

- 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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Plasma Concentration (Cmax)

Outcome Description:

The Cmax is the maximum observed plasma concentration of study drug.

Outcome Time Frame:

Pre-dose, 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48 hours post-dose

Safety Issue:


Principal Investigator

Xian-Janssen Pharmaceutical Ltd. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Xian-Janssen Pharmaceutical Ltd.


China: Food and Drug Administration

Study ID:




Start Date:

November 2011

Completion Date:

August 2012

Related Keywords:

  • Pain
  • Pain
  • Hydromorphone
  • OROS