MedTrace Logo

ABSK091 Food Effect Study in Healthy Subjects

NCT05533788 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2022-09-09

No results posted yet for this study

Summary

In this study, a single oral dose of the tablet formulation administered under fed conditions will be compared to administration under fasted conditions to assess the effects of a high-fat meal on the rate and extent of absorption and exposure.

Study ABSK091-101 is a single-center, Phase 1, open-label, randomized, two-period, two-sequence, and crossover study in healthy subjects.

Conditions

  • Health, Subjective
  • Food-drug Interaction

Interventions

DRUG

ABSK091 tablet

ABSK091 tablet which is being developed for the treatment of patients with advanced solid tumors

Sponsors & Collaborators

  • Abbisko Therapeutics Co, Ltd

    lead INDUSTRY

Principal Investigators

  • Yuan Lu, PhD · Abbisko Therapeutics Co, Ltd

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-08
Primary Completion
2021-04-30
Completion
2021-04-30

Countries

  • Taiwan

Study Locations

More Related Trials

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 NCT05533788 on ClinicalTrials.gov