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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)

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ClinicalTrials.gov Identifier: NCT01318655
Recruitment Status : Completed
First Posted : March 18, 2011
Last Update Posted : August 25, 2011
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Healthy Drug: NKTR-118 Drug: Placebo Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2011
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Naloxegol

Arm Intervention/treatment
Experimental: NKTR-118 Drug: NKTR-118
Tablet, Oral, Once daily

Placebo Comparator: Placebo Drug: Placebo
Tablet, Oral, Once daily




Primary Outcome Measures :
  1. Investigate the safety and tolerability of NKTR-118 using incidence of Adverse Events

Secondary Outcome Measures :
  1. Assessment of drug concentrations in plasma by characterizing PK parameters (AUC)
  2. Assessment of drug concentrations in plasma by characterizing PK parameters (Cmax)


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01318655


Locations
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Japan
Research Site
"Chuo-ku", "Fukuoka", Japan
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Mark Sostek, MD AstraZeneca
Principal Investigator: Shunji Matsuki, MD Kyusyu Clinical Phramacology Research Clinic
Principal Investigator: Yukiya Sasaki, MD AstraZeneca
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01318655    
Other Study ID Numbers: D3820C00020
First Posted: March 18, 2011    Key Record Dates
Last Update Posted: August 25, 2011
Last Verified: August 2011
Keywords provided by AstraZeneca:
Phase I
Japan
SAD
MAD
Additional relevant MeSH terms:
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Naloxegol
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents