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Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP1617 in Healthy Adult Non-Asian and Japanese Subjects Including Assessment of a Food Effect

NCT04077879 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2024-10-23

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and tolerability of single ascending oral doses of ASP1617 in healthy adult non-Asian and Japanese male and female participants.

This study also evaluate the pharmacokinetics and determine the effect of food on the pharmacokinetics of a single oral dose of ASP1617.

Conditions

  • Healthy Volunteers

Interventions

DRUG

ASP1617

Oral

DRUG

Placebo

Oral

Sponsors & Collaborators

  • Astellas Pharma Global Development, Inc.

    lead INDUSTRY

Principal Investigators

  • Senior Director · Astellas Pharma Global Development, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-19
Primary Completion
2021-06-12
Completion
2021-06-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04077879 on ClinicalTrials.gov