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Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Food Effect and DDI of Ascending Doses of the MEK Inhibitor Zapnometinib

NCT05555823 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2023-08-01

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and tolerability of ascending doses of the MEK-inhibitor zapnometinib (ATR-002) given as single doses (SAD Part) and as multiple doses for 7 days (MAD Part) in healthy subjects.

Conditions

  • Healthy

Interventions

DRUG

ATR-002

300 mg tablets for oral intake

DRUG

Placebo

matching tablets for oral intake

DRUG

Repaglinide

0,5 mg tablets for oral intake

DRUG

Celecoxib

100 mg capsules for oral intake

Sponsors & Collaborators

  • Atriva Therapeutics GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-06-23
Primary Completion
2023-07-20
Completion
2023-07-20

Countries

  • Germany

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 NCT05555823 on ClinicalTrials.gov