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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01318655

Acronym

Japan SMAD

Enrollment

Registered

2011-03-18

Start date

2011-03-31

Completion date

2011-07-31

Last updated

2011-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Phase I, Japan, SAD, MAD

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

Interventions

DRUGNKTR-118

Tablet, Oral, Once daily

DRUGPlacebo

Tablet, Oral, Once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Investigate the safety and tolerability of NKTR-118 using incidence of Adverse Events	—

Secondary

Measure	Time frame
Assessment of drug concentrations in plasma by characterizing PK parameters (AUC)	—
Assessment of drug concentrations in plasma by characterizing PK parameters (Cmax)	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026