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:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01318655
First received: March 17, 2011
Last updated: August 24, 2011
Last verified: August 2011
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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
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 May 23, 2013