Study identifier:D3820C00012
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
An Open-label, 1-sequence, 3-period, 3-treatment, Crossover Study to Assess the Effects of Ketoconazole on the Pharmacokinetics of NKTR-118 in Healthy Subjects
Bioavailability, Healthy Volunteers, Drug- drug interactions
Phase 1
Yes
NKTR-118, Ketoconazole
All
22
Interventional
18 Years - 55 Years
Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verified 01 Oct 2014 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Part 1 - A Single dose NKTR-118 25 mg on Day 1 only | Drug: NKTR-118 Oral 25 mg |
Active Comparator: Part 1 - B Ketoconazole 400 mg once daily on Days 4 to 8 | Drug: Ketoconazole Oral 400 mg |
Active Comparator: Part 1- C Ketoconazole 400 mg plus NKTR-118 25 mg on Day 7 | Drug: NKTR-118 Oral 25 mg Drug: Ketoconazole Oral 400 mg |