Pharmacokinetics of 9-cis-retinoic Acid (Alitretinoin, Toctino®) in Patients With Hepatic Disease

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to investigate whether liver patients may tolerate alitretinoin by comparing metabolism in 8 such patients with the metabolism in 8 healthy controls

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital, Gentofte, Copenhagen
• Treatments: Alitretinoin; Isotretinoin; Tretinoin

Criteria

Inclusion Criteria:

1. Be medically stable for at least 1 month before the intake of 9-cis-RA.

2. There must be an ultrasound scan of liver and abdomen within the last 3 months (liver size, ascites).

3. In women of childbearing age, there must be a negative pregnancy test, while that to be used adequate contraception (the pill, coil or surgical sterilization) at least 1 month after taking the study medication.

Exclusion Criteria:

1. Clinically significant deviations in routine blood tests (hematology, electrolytes and kid-ney, urinalysis). Differences attributable to underlying liver disease are excluded.

2. Encephalopathy (> grade II)

3. Concomitant treatment with drugs predominantly metabolised in the liver by CYP3A4.

4. Clinically significant ECG changes, cardiovascular disease and AMI within the last 12 months

5. Affected renal function judged by Cockcroft-Gault formula.

6. Epilepsy or significant neurological disease that requires drug therapy.

7. History of cerebrovascular relapse

8. Esophagus bleeding

9. Severe ascites

10. HIV

11. Mental illness.

12. Active cancer

13. Pregnancy or pregnancy plan within 3 months.

14. Breastfeeding women.

15. Participation in other clinical projects.

16. Intake of clinical trial medication in the past month.