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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
History of Changes

August 31, 2011
September 22, 2011
June 2011
September 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01427387 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate Safety of Multiple Dose of ASP0456 in Healthy Subjects
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-

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
  • Healthy
  • Pharmacokinetics of ASP0456
  • Drug: ASP0456
    oral
    Other Name: linaclotide
  • Drug: Placebo
    oral
  • Experimental: Part-1 ASP group
    ASP0456 receiving group
    Intervention: Drug: ASP0456
  • Placebo Comparator: Part-1 Placebo group
    Placebo treatment
    Intervention: Drug: Placebo
  • Experimental: Part-2 group
    cross-over study group to evaluate food effect on ASP0456 plasma concentration
    Intervention: Drug: ASP0456
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 44 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01427387
0456-CL-0012
No
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Chair: Use Cental Contact Astellas Pharma Inc
Astellas Pharma Inc
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP