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NCT01891526 Clinical Trial

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

Hepatic Insufficiency Clinical Trial

Official title:
The Pharmacokinetics of a Single Dose of 9-cis-retinoic Acid (Alitretinoin, Toctino®) in Patients With Moderate to Severe Hepatic Insufficiency

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01891526
Other study ID # 2010-338
Secondary ID Allitretinoin
Status Completed
Phase N/A
First received June 21, 2013
Last updated June 28, 2013
Start date December 2010
Est. completion date June 2012

Study information
Verified date June 2013
Source University Hospital, Gentofte, Copenhagen
Contact n/a
Is FDA regulated No
Health authority The Danish National Committee on Biomedical Research Ethics, Denmark:United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility 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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Denmark Gentofte Hospital Gentofte

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary A comparison of the metabolisation of retinoic acid in patients with hepatic insufficiency and controls Analysis on samples 24 hours No
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