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

NCT01261923 | Completed Phase 1

• 1 other identifier: Eudra CT 2010-020212-11
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hepatic Insufficiency

Outcome Measures

Primary Outcomes (1)

• The investigators wish to investigate whether the metabolism of alitretinoin differs between healthy controls and patients with moderate to severe hepatic disease

  The metabolism of alitretinoin will be examined by measuring blood concentrations after time: 0 , ¼, ½, ¾, 1, 1¼, 1½, 2, 2½, 3, 3½, 4, 5, 6, 8, 10, 12 and 24 hours.

  2 years

Study Arms (2)

Alitretinoin - Hepatic Insufficiency

EXPERIMENTAL

metabolism of 30 mg alitretinoin single dose in 8 patients with Hepatic Insufficiency

Drug: Alitretinoin

Alitretinoin - Hepatic Insufficiency Controls

EXPERIMENTAL

metabolism of 30 mg alitretinoin single dose in 8 healthy controls.

Drug: Alitretinoin

Interventions

Alitretinoin DRUG

30 mg capsule of 9-cis-retinoic-acid (9-cis-RA)(Alitretinoin, Toctino®)

Also known as: 9-cis-retinoic-acid (9-cis-RA)(Alitretinoin, Toctino®)

Alitretinoin - Hepatic Insufficiency; Alitretinoin - Hepatic Insufficiency Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be medically stable for at least 1 month before the intake of 9-cis-RA.
• There must be an ultrasound scan of liver and abdomen within the last 3 months (liver size, ascites).
• 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.

You may not qualify if:

• Clinically significant deviations in routine blood tests (hematology, electrolytes and kid-ney, urinalysis). Differences attributable to underlying liver disease are excluded.
• Encephalopathy (\> grade II)
• Concomitant treatment with drugs predominantly metabolised in the liver by CYP3A4.
• Clinically significant ECG changes, cardiovascular disease and AMI within the last 12 months
• Affected renal function judged by Cockcroft-Gault formula.
• Epilepsy or significant neurological disease that requires drug therapy.
• History of cerebrovascular relapse
• Esophagus bleeding
• Severe ascites
• HIV
• Mental illness.
• Active cancer
• Pregnancy or pregnancy plan within 3 months.
• Breastfeeding women.
• Participation in other clinical projects.

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead

Study Sites (1)

Gentofte Hospital

Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Hepatic Insufficiency

Interventions

Alitretinoin

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Tretinoin; Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Officials

• Frederik Grønhøj, MD DMSci

  Gentofte Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 15, 2010
• First Posted: December 17, 2010
• Study Start: December 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: January 29, 2013

Record last verified: 2013-01

Locations

DK (1)