Single Dose of 9-cis-retinoic Acid in Hepatic Patients

Overview

To test whether patients with hepatic insufficiency can tolerate one oral dose of 9-cis-retinoic acid and to test whether the metabolism of retinoic acid is altered.

Full Title of Study: “The Pharmacokinetics of a Single Dose of 9-cis-retinoic Acid (Alitretinoin, Toctino®) in Patients With Moderate to Severe Hepatic Insufficiency”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2012

Interventions

  • Drug: 9-cis-retinoic acid
    • Single dose of 9-cis-retinoic acid (Capsule 30 mg) as oral exposure

Arms, Groups and Cohorts

  • Hepatic patients
    • patients with hepatic insufficiency
  • Healthy Controls
    • Healthy adults

Clinical Trial Outcome Measures

Primary Measures

  • A comparison of the metabolisation of retinoic acid in patients with hepatic insufficiency and controls
    • Time Frame: 24 hours
    • Analysis on samples

Participating in This Clinical Trial

Inclusion Criteria

1. Have biopsy verified hepatic insufficiency 2. Medically stable. 3. Ultra sonic examination of lever within the past 3 months 4. No pregnancy documented in women. use of anticonception during study and 1 month after Exclusion criteria:

1. Odd blood counts and samples not related to hepatic disease 2. encephalopathy (> grad II) 3. concomitant treatment with pharmaca that is metabolized by CYP3A4 in the liver. 4. Cardiac disease 5. Kidney disease 6. Epilepsia 7. Stroke 8. Esophagal bleeding 9. Severe ascites 10. HIV-positivity 11. Psychiatric disorder 12. Cancer 13. pregnancy or lactating women.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Hospital, Gentofte, Copenhagen
  • Provider of Information About this Clinical Study
    • Principal Investigator: Frederik Grønlund MD DMSci, MD – University Hospital, Gentofte, Copenhagen

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.