Effect of Ketoconazole on Regorafenib (BAY73-4506) Pharmacokinetics

Pharmacokinetics Clinical Trial

Official title:

A Phase I, Non-Randomized, Open Label Study to Determine the Effetc of Ketoconazole on the Pharmacokinetics of a Single Oral Dose of Regorafenib (BAY73-4506) in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01318265
• Other study ID #: 12435
• Status: Completed
• Phase: Phase 1
• First received: February 18, 2011
• Last updated: October 31, 2014
• Start date: March 2011
• Est. completion date: July 2011

Study information

• Verified date: October 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to estimate the effect of multiple doses of ketoconazole on the pharmacokinetics of a single dose of BAY73-4506 in healthy male volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy male subjects between 18 and 45 years of age, inclusive

• BMI between 18 and 32 kg/m2 inclusive

Exclusion Criteria:

• Subjects with evidence of disease, conditions affecting drug absorption or metabolism

• Treatment with other investigational drug within 30 days

• History of regular alcohol or recreational drug consumption

• Use of prescription drugs within 14 days

• Use of nonprescription drugs and dietary supplement within 7 days

• Blood donation within 30 days

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Drug:
• Regorafenib (BAY73-4506); Regorafenib (BAY73-4506) plus ketoconazole
Treatment 1: A single 160 mg dose of BAY73-4506. Treatment 2: Ketoconazole 400 mg once daily from Day -4 to Day 3. A single 160 mg dose of BAY73-4506 on Day 1.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration versus time curve from zero to infinity ( Plasma AUCinf) of BAY73-4506 given alone or with ketoconazole.		1 month	No
Primary	Peak plasma concentration (Cmax) of BAY73-4506 given alone or with ketoconazole		1 month	No
Secondary	Plasma AUCinf of metabolites of a single oral dose BAY73-4506 given alone or with ketoconazole.		1 month	No
Secondary	Plasma Cmax of metabolites of a single oral dose BAY73-4506 given alone or with ketoconazole.		1 month	No
Secondary	Number of subjects with adverse events following a single oral dose of BAY73-4506, adminstered alone and concomitantly with ketoconazole.		1 month	Yes

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