Single and Multiple Ascending Dose Study for NKTR-118 and Cross-over Study to Investigate the Effect of Food for NKTR-118 in Japanese Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: NKTR-118; Drug: Placebo

• Registration Number: NCT01318655
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of NKTR-118 with healthy subjects.

Detailed Description

A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of NKTR-118 following single and multiple ascending oral dose administration in healthy young and elderly Japanese subjects, and an Open Randomized, Crossover Study to Investigate the Effect of Food on the Pharmacokinetics after single oral doses of NKTR-118 in healthy male Japanese subjects

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-17
• Study First Submitted QC: 2011-03-17
• Study First Posted: 2011-03-18
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-24
• Last Update Posted: 2011-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 20 Years to 45 Years, 65 Years to 80 Years
• Body mass index (BMI): 18 to 27 kg/m
• Male subjects should be willing to use barrier contraception ie, condoms, from the day of dosing until 3 months after dosing with the investigational product.
• Non-smokers or ex-smokers (not smoked in the past 3 months).

Exclusion Criteria

• Clinically relevant disease and/or abnormalities (past or present)
• Clinically relevant abnormalities in physical examinations,vital signs,clinical chemistry, hematology or urinalysis as judged by the investigator
• Use of any prescribed or non-prescribed medication including herbal remedies, vitamins and minerals during the two weeks prior to the first administration of investigational product

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NKTR-118	NKTR-118	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Investigate the safety and tolerability of NKTR-118 using incidence of Adverse Events

Secondary Outcome Measures

Name	Time	Method
Assessment of drug concentrations in plasma by characterizing PK parameters (AUC)
Assessment of drug concentrations in plasma by characterizing PK parameters (Cmax)

Trial Locations

Locations (1)

Research Site; 🇯🇵 "Chuo-ku", "Fukuoka", Japan