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Pharmacokinetics and Metabolism of Hydrocodone Bitartrate Extended-Release (HC-ER) in Subjects With Renal Impairment

Evaluation of the Effect of Renal Impairment on the Pharmacokinetics and Metabolism of Hydrocodone and Its Metabolites Following Administration of Hydrocodone Bitartrate Extended-Release (HC-ER) 20 mg Capsules

NCT02244762•Zogenix, Inc.

View on ClinicalTrials.gov

Summary

Determine the influence of renal impairment on the pharmacokinetics and metabolism of Hydrocodone Bitartrate Extended-Release (HC-ER) 20 mg capsules

Detailed Description

Pharmacokinetics and relative bioavailability of hydrocodone and its metabolites under fasted conditions

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Male or non-pregnant, non-lactating females.
•2. Subjects were 18-80 years old.
•3. Subjects must have had a clinical diagnosis of chronic renal impairment for duration of at least 6 months classified as mild, moderate or severe per Cockcroft Gault criteria (see Appendix A)
•4. Renal insufficiency should have been stable with no acute episodes of illness within the previous 2 months due to deterioration of renal function due to any etiology.
•5. Female subjects of childbearing potential including those who had a tubal ligation surgery but excluding those who have not experienced a menstrual period for a minimum of 2 years, must have had a negative pregnancy test at the Screening and Day -1 visits, and must consent to use a medically-acceptable method of contraception throughout the entire study period and for 1 week after the study is completed. Medically acceptable methods of contraception include but were not limited to abstinence, birth control pills or patches, vaginal rings, diaphragm with vaginal spermicide, intrauterine device (IUD), and progestin implant or injection (used consistently for 3 months prior to study dosing).
•6. Subjects must have voluntarily provided written informed consent.
•7. Subjects, in the Investigator's opinion, must have been able to complete all study procedures.
•2a. Must have matched by age (± 10 years) and BMI (±10% of BMI) with some consideration for race and gender to subjects with renal impairment.
•3b. Were medically healthy with no clinically significant abnormalities in their laboratory profile as deemed by the investigator.

Exclusion Criteria

•Subjects were not be eligible for the study if they meet any of the following criteria:
•1. Women who were pregnant or breastfeeding.
•2. Any clinically significant condition that would, in the opinion of the Investigator, preclude study participation.
•3. Uncontrolled blood pressure, i.e., subjects has a sitting systolic blood pressure \>180 mmHg or \<90 mmHg, and/or a sitting diastolic blood pressure \>120 mmHg or \<50 mmHg at screening.
•4. A Body mass Index (BMI) \>40 kg/m2.
•5. A known allergy or hypersensitivity to hydrocodone, or other opioids.
•6. Have taken any investigational drug within 30 days prior to the Day 1 visit or be currently enrolled in another investigational drug study.
•7. Have used a monoamine oxidase inhibitor within 14 days prior to the Day 1 visit.
•8. Were taking opioids during the 30 days prior to Day 1 or needing to take opioids during the study period.
•9. Positive for HIV. Healthy control subjects must have not been Hepatitis C Virus (HCV) positive, renal-impaired subjects can be HCV positive but should not be receiving treatment.
+5 more criteria

Key Dates

Start Date

February 1, 2011

Primary Completion Date

May 1, 2011

Completion Date

May 1, 2011

Last Updated

November 10, 2022

Enrollment

ACTUAL participants

Conditions

Renal Impairment

Interventions

20 mg HC-ER

DRUG

20 mg HC-ER

DRUG

20 mg HC-ER

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 10, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pharmacokinetics and Metabolism of Hydrocodone Bitartrate Extended-Release (HC-ER) in Subjects With Renal Impairment

Inclusion Criteria

Exclusion Criteria

Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD2373)

A Study of Pharmacokinetics and Safety of LY3537031 in Participants With Normal Renal Function and Participants With Renal Impairment

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DESIR. Evaluation of the Pre-therapeutic Activity of Dihydropyrimidine dEShydrogenase (DPD) in Patients With Cancer and/or Renal Failure