A Study to Evaluate Safety of Multiple Dose of ASP0456 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01427387
First received: August 31, 2011
Last updated: September 22, 2011
Last verified: September 2011
  Purpose

A study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending dose of ASP0456 in non-elderly healthy subjects. Two dosing condition, pre-prandial and postprandial administrations, is compared.


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 Double-blind, Placebo-controlled, Multiple Ascending Dose Study / Investigational Study for Dose Timing Selection in Non Elderly Healthy Subjects-

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Pharmacokinetics (such as Cmax, AUC and t1/2 etc.) 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: 44
Study Start Date: June 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part-1 ASP group
ASP0456 receiving group
Drug: ASP0456
oral
Other Name: linaclotide
Placebo Comparator: Part-1 Placebo group
Placebo treatment
Drug: Placebo
oral
Experimental: Part-2 group
cross-over study group to evaluate food effect on ASP0456 plasma concentration
Drug: ASP0456
oral
Other Name: linaclotide

  Eligibility

Ages Eligible for Study:   20 Years to 44 Years
Genders Eligible for Study:   Both
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);

    • female ≥40.0 kg,<70.0 kg
    • male ≥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: NCT01427387

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

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01427387     History of Changes
Other Study ID Numbers: 0456-CL-0012
Study First Received: August 31, 2011
Last Updated: September 22, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
ASP0456
Pharmacokinetics
safety
tolerability
food effect

ClinicalTrials.gov processed this record on April 17, 2014