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Completed

NCT Number: NCT01427387

A Study to Evaluate Safety of Multiple Dose of ASP0456 in 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.

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Key information

Conditions

Healthy Pharmacokinetics of ASP0456

Age range

20 year–44 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kantou, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASP0456

Drug

oral

Other names: linaclotide

Placebo

Drug

oral

Primary outcomes

  1. Pharmacokinetics (such as Cmax, AUC and t1/2 etc.) of ASP0456 assessed by its plasma concentration change

    Time frame: For 48 hours after dosing

Secondary outcomes

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

    Time frame: For 48 hours after dosing

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study 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-

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Sep 1, 2011
Registry last updated
Sep 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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