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Completed

NCT Number: NCT01318655

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

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

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Key information

Conditions

Healthy

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Chūōku, Fukuoka, Japan

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NKTR-118

Drug

Tablet, Oral, Once daily

Placebo

Drug

Tablet, Oral, Once daily

Primary outcomes

  1. Investigate the safety and tolerability of NKTR-118 using incidence of Adverse Events

Secondary outcomes

  1. Assessment of drug concentrations in plasma by characterizing PK parameters (AUC)

  2. Assessment of drug concentrations in plasma by characterizing PK parameters (Cmax)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: Japan SMAD

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 18, 2011
Registry last updated
Aug 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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