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A Safety and Pharmacokinetics Study of ASP0456 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01279915
First received: January 18, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

A study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending dose of ASP0456 in non-elderly healthy subjects.


Condition Intervention Phase
Healthy
Pharmacokinetics of ASP0456
 Drug: ASP0456
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: Phase I Study of ASP0456 - A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study in Non-elderly Healthy Male Subjects

Resource links provided by NLM:

Drug Information available for: Linaclotide
U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Pharmacokinetics of ASP0456 assessed by its plasma concentration change [ Time Frame: For 48 hours after dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety assessed by the incidence of adverse events, vital signs, 12-lead ECGs and labo tests [ Time Frame: For 48 hours after dosing ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: October 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP group
ASP0456 receiving group
 Drug: ASP0456
oral
Other Name: linaclotide
Placebo Comparator: Placebo group
Placebo treatment
 Drug: Placebo
oral

  Eligibility

Ages Eligible for Study:   20 Years to 44 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy, as judged by the investigator/subinvestigator based on the results of physical examination and all tests obtained
  • Body weight (at screening); ≥50.0 kg,<80.0 kg
  • BMI(at screening): ≥17.6,<26.4

Exclusion Criteria:

  • Received any investigational drugs in other clinical or post-marketing studies within 120 days before the study
  • Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the study
  • Received medication within 10 days before dose is administered or is scheduled to receive medication
  • History of drug allergies
  • Upper (e.g. nausea, vomiting, stomachache) and lower (e.g. abdominal pain) gastrointestinal disease within 7 days before the study
  • Concurrent or previous hepatic disease
  • Concurrent or previous heart disease
  • Concurrent or previous renal disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01279915

Locations
Japan
Kantou, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT01279915     History of Changes
Other Study ID Numbers: 0456-CL-0011
Study First Received: January 18, 2011
Last Updated: January 18, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
ASP0456
Pharmacokinetics
safety
tolerability

ClinicalTrials.gov processed this record on May 19, 2013