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

NCT01427387 | Completed Phase 1

• 1 other identifier: 0456-CL-0012
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy; Pharmacokinetics of ASP0456

Keywords

ASP0456; Pharmacokinetics; safety; tolerability; food effect

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics (such as Cmax, AUC and t1/2 etc.) 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 (3)

Part-1 ASP group

EXPERIMENTAL

ASP0456 receiving group

Drug: ASP0456

Part-1 Placebo group

PLACEBO COMPARATOR

Placebo treatment

Drug: Placebo

Part-2 group

EXPERIMENTAL

cross-over study group to evaluate food effect on ASP0456 plasma concentration

Drug: ASP0456

Interventions

ASP0456 DRUG

oral

Also known as: linaclotide

Part-1 ASP group; Part-2 group

Placebo DRUG

oral

Part-1 Placebo group

Eligibility Criteria

• Age: 20 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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);
• female ≥40.0 kg,\<70.0 kg
• male ≥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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Unknown Facility

Kantou, Japan

Location

MeSH Terms

Interventions

linaclotide

Study Officials

• Use Cental 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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2011
• First Posted: September 1, 2011
• Study Start: June 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: September 23, 2011

Record last verified: 2011-09

Locations

JP (1)