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 (Japan SMAD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01318655
First received: March 17, 2011
Last updated: August 24, 2011
Last verified: August 2011
  Purpose

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


Condition Intervention Phase
Healthy
Drug: NKTR-118
Drug: Placebo
Phase 1

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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Investigate the safety and tolerability of NKTR-118 using incidence of Adverse Events [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assessment of drug concentrations in plasma by characterizing PK parameters (AUC) [ Designated as safety issue: No ]
  • Assessment of drug concentrations in plasma by characterizing PK parameters (Cmax) [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: March 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NKTR-118 Drug: NKTR-118
Tablet, Oral, Once daily
Placebo Comparator: Placebo Drug: Placebo
Tablet, Oral, Once daily

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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01318655

Locations
Japan
Research Site
"Chuo-ku", "Fukuoka", Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Mark Sostek, MD AstraZeneca
Principal Investigator: Shunji Matsuki, MD Kyusyu Clinical Phramacology Research Clinic
Principal Investigator: Yukiya Sasaki, MD AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01318655     History of Changes
Other Study ID Numbers: D3820C00020
Study First Received: March 17, 2011
Last Updated: August 24, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
Phase I
Japan
SAD
MAD

ClinicalTrials.gov processed this record on August 28, 2014