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

Healthy Clinical Trial

— Japan SMAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01318655
• Other study ID #: D3820C00020
• Status: Completed
• Phase: Phase 1
• First received: March 17, 2011
• Last updated: August 24, 2011
• Start date: March 2011
• Est. completion date: July 2011

Study information

• Verified date: August 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• NKTR-118
Tablet, Oral, Once daily
• Placebo
Tablet, Oral, Once daily

Locations

Country	Name	City	State
Japan	Research Site	"Chuo-ku"	"Fukuoka"

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigate the safety and tolerability of NKTR-118 using incidence of Adverse Events			Yes
Secondary	Assessment of drug concentrations in plasma by characterizing PK parameters (AUC)			No
Secondary	Assessment of drug concentrations in plasma by characterizing PK parameters (Cmax)			No