NCT01969669

A Study to Assess the Effect of Ketoconazole on the Metabolism of ABT-199

A Phase 1 Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of ABT-199

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label multicenter, study to assess the pharmacokinetic interaction of ketoconazole with ABT-199 in up to 12 subjects with relapsed or refractory non-Hodgkin's lymphoma.

Detailed description

This is a Phase 1 study designed to assess how the body processes the study drug ABT-199 when taken alone and in combination with ketoconazole and to assess the safety of ABT-199 in combination with ketoconazole. Subjects may enroll in a separate extension study to continue receiving ABT-199 after completion of this study.

Conditions

• Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	ABT-199	Subjects will be dosed with ABT-199, then dosed with ABT-199 in combination with ketoconazole
DRUG	Ketoconazole	Subjects will be dosed with ABT-199, then dosed with ABT-199 in combination with ketoconazole

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2013-10-25
• Last updated: 2017-11-20

Locations

3 sites across 1 country: United States