Study to Evaluate the Effect of Renal Function on the Single-Dose Pharmacokinetics of BAY 43-9006

NCT00119639 | Completed Phase 1

• 1 other identifier: 11804
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a 400 mg (2 x 200 mg tablets) sorafenib single dose, open-label study being conducted to compare the pharmacokinetics of plasma and urine and safety of sorafenib in subjects with severe, moderate, and mild renal impairment with those exhibiting normal renal function.

Conditions

Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics of sorafenib in plasma and urine; single-dose safety of sorafenib in patients with renal impairment

  2 weeks

Study Arms (1)

Arm 1

EXPERIMENTAL

Drug: Sorafenib (BAY43-9006, Nexavar)

Interventions

Sorafenib (BAY43-9006, Nexavar) DRUG

All subjects were given a open-label, single dose of 400mg sorafenib

Arm 1

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Post menopausal females
• Surgically sterile females
• Body Mass Index between 18-37
• Subjects with Clcr greater than 80 mL/min
• Subjects with Clcr 50 to 80 mL/min
• Subjects with Clcr 30 to 50 mL/min
• Clcr less than 30 mL/min but not on dialysis
• Subjects must test negative for HIV
• Subjects must test negative for drugs of abuse at screening

You may not qualify if:

• All Subjects :
• Concomitant Medication: Treatment with CYP3A4 inducers, such as rifampin and St. John's Wort within 14 days of Day 1 until they leave the clinic on Day 7
• Donation of blood within 30 days of Day 1
• Recent participation in an investigational drug study during which active medication was given within 30 days of Day 1
• History of gastrointestinal disorder that could result in incomplete absorption of study drug
• Malignancy
• Significant neurologic or psychiatric disorders
• History of drug or alcohol abuse in year prior to screening for this trial, or current intake or \>14 standard alcoholic drinks per week
• Prior history of epilepsy or other seizure disorders
• Known hypersensitivity to inhibitors of raf kinase or VEGFR-2
• Females of child-bearing potential
• Smoking \> 10 cigarettes/day or equivalent
• Excessive consumption (more than five 8-oz. cups/day) of coffee or caffeine
• Healthy Volunteer:
• Existing failure of a major organ system, or a medical disorder that would impair the subject's ability to complete the study (in the opinion of the investigator or the sponsor), eg history of blood coagulation disorders

Sponsors & Collaborators

• Bayer: lead

MeSH Terms

Conditions

Kidney Diseases

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 8, 2005
• First Posted: July 14, 2005
• Study Start: June 1, 2005
• Study Completion: December 1, 2005
• Last Updated: January 16, 2009

Record last verified: 2009-01