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

NCT01824524 | Completed Phase 1

• 2 other identifiers: CR01807042801PAI1012
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Pain

Keywords

Pain; Hydromorphone; OROS

Outcome Measures

Primary Outcomes (5)

• 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

• Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours (AUC[0-48])

  The AUC(0-48) is the area under the plasma concentration-time curve from time 0 to 48 hours post-dose.

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

• Area Under the Plasma Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC[0-last])

  The AUC(0-last) is area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration.

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

• Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])

  The AUC(0-infinity) is the area under the plasma concentration-time curve from time 0 to extrapolated infinite time, calculated as the sum of AUC(0-last) and C(last)/tau where C(last) is the last observed quantifiable concentration and 'tau' is the first-order rate constant associated with the terminal portion of the curve.

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

• Percentage of AUC Obtained by Extrapolation (%AUC[inf,ex])

  Percentage of AUC obtained by extrapolation (%AUC\[inf,ex\]) is calculated by dividing the difference of AUC(0-infinity) and AUC(0-last) by AUC(0-infinity) and then multiplying by 100 (AUC\[0-infinity\] - AUC\[0-last\])\*100/AUC\[0-infinity\].

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

Secondary Outcomes (5)

• Time to Reach the Maximum Plasma Concentration (tmax)

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

• Terminal Elimination Half Life (t1/2)

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

• First-Order Rate Constant Associated With the Terminal Portion of the Curve

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

• Apparent Clearance (CL/F)

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

• Apparent Volume of Distribution (Vd/F)

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

Study Arms (1)

OROS Hydromorphone

EXPERIMENTAL

Drug: Hydromorphone

Interventions

Hydromorphone DRUG

Participants will be administered a single dose of Osmotic Release Oral System (OROS) hydromorphone tablet of 8 milligram (mg) orally on Day 1 under fasting conditions.

OROS Hydromorphone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xian-Janssen Pharmaceutical Ltd.: lead

Study Sites (2)

Unknown Facility

Beijing, China

Location

Unknown Facility

Changsha, China

Location

Related Links

• An Open-Label Study to Evaluate the Single Dose Pharmacokinetic Profile and Safety of OROS® Hydromorphone in Chinese Subjects With Cancer who are not Opioid Tolerant

MeSH Terms

Conditions

Pain

Interventions

Hydromorphone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Xian-Janssen Pharmaceutical Ltd. Clinical Trial

  Xian-Janssen Pharmaceutical Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2013
• First Posted: April 4, 2013
• Study Start: December 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 15, 2014

Record last verified: 2014-08

Locations

CN (2)