NCT01279915

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 20, 2011

Completed
Last Updated

January 20, 2011

Status Verified

January 1, 2011

Enrollment Period

3 months

First QC Date

January 18, 2011

Last Update Submit

January 18, 2011

Conditions

HealthyPharmacokinetics of ASP0456

Keywords

ASP0456Pharmacokineticssafetytolerability

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics of ASP0456 assessed by its plasma concentration change

    For 48 hours after dosing

Secondary Outcomes (1)

  • Safety assessed by the incidence of adverse events, vital signs, 12-lead ECGs and labo tests

    For 48 hours after dosing

Study Arms (2)

ASP group

EXPERIMENTAL

ASP0456 receiving group

Drug: ASP0456

Placebo group

PLACEBO COMPARATOR

Placebo treatment

Drug: Placebo

Interventions

ASP0456DRUG

oral

Also known as: linaclotide
ASP group
PlaceboDRUG

oral

Placebo group

Eligibility Criteria

Age20 Years - 44 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Kantou, Japan

Location

MeSH Terms

Interventions

linaclotide

Study Officials

  • Use Central Contact

    Astellas Pharma Inc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 18, 2011

First Posted

January 20, 2011

Study Start

October 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

January 20, 2011

Record last verified: 2011-01

Locations

JP(1)