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-

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
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: 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 October 20, 2014