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Phase 1 Study of ATR-002

NCT04385420 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2020-05-13

No results posted yet for this study

Summary

This was a combination of a single ascending dose (SAD) study to evaluate the safety, tolerability, and PK of 3 oral doses of a MEK inhibitor and a multiple ascending dose (MAD) study of 3 oral doses of a MEK inhibitor.

Subjects were to be enrolled in 3 different cohorts in the SAD and 3 different cohorts in the MAD and were to be randomly (blinded) allocated to active treatment or placebo (each cohort consisted of 8 subjects receiving active treatment and 2 subjects receiving placebo).

Conditions

Interventions

DRUG

ATR-002 MEK Inhibitor

Drug ATR-002 administered as film-coated tablet via oral route

DRUG

Placebo oral tablet

Placebo film-coated tablet administered via oral route

Sponsors & Collaborators

  • SGS Life Sciences, a division of SGS Belgium NV

    collaborator OTHER

  • Atriva Therapeutics GmbH

    lead INDUSTRY

Principal Investigators

  • Bram Volckaert, MD · SGS Belgium NV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-04-24
Primary Completion
2019-08-26
Completion
2019-08-26

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

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 NCT04385420 on ClinicalTrials.gov