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Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of SLC-391 in Healthy Adult Subjects

NCT05278845 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-08-01

No results posted yet for this study

Summary

This will be a single center, Phase 1, open-label, randomized, single dose, 2-period, 2-sequence, crossover study to evaluate the PK, safety, and tolerability of a single oral dose of SLC-391 under fed and fasted conditions in approximately 22 healthy male and non-childbearing potential female subjects.

Subjects will be randomized in a 1:1 ratio to one of two treatment sequences with 11 subjects per treatment sequence. Each subject will receive both treatments (Treatment A and Treatment B) with a washout period of at least 7 days between successive SLC-391.

Conditions

  • Food-drug Interaction

Interventions

DRUG

SLC-391

SLC-391 is an AXL inhibitor

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • SignalChem Lifesciences Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2022-02-12
Primary Completion
2022-06-14
Completion
2022-06-14

Countries

  • Canada

Study Locations

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Entities

Companies

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 NCT05278845 on ClinicalTrials.gov