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Completed Phase 1 Interventional Accepts healthy volunteers

A Trial to Investigate Safety and Pharmacokinetics of GRT6019, Including Food Effect, in Healthy Male Participants

ClinicalTrials.gov ID: NCT07317063

Public ClinicalTrials.gov record NCT07317063. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 10, 2026, 6:32 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-label, Single-center Trial Evaluating the Safety, Tolerability, and Pharmacokinetics of a Single Dose of GRT6019, Including Food Effect, in Healthy Male Participants

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this trial is to evaluate the safety, tolerability, and Pharmacokinetics (PK) of a single oral dose of GRT6019 in healthy male participants, including food effect. This is an open-label, single-dose, single-center Phase I trial with healthy male participants. The trial will consist of 2 cohorts with a total duration of approximately 7 weeks, including a 28-day Screening Period. The participants will receive a single dose of GRT6019 administered on Day 1 and will remain at the clinic for 7 additional days. Following the in-house stay, there will be 2 Follow-up Visits up until Day 23, with 3 clinic visits scheduled

Study identification

NCT ID
NCT07317063
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Grünenthal GmbH
Industry
Enrollment
18 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 55 Years
Sex
Male
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 20, 2025
Primary completion
Jan 5, 2026
Completion
Jan 5, 2026
Last update posted
Feb 12, 2026

2025 – 2026

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Biotrial, Inc Newark New Jersey 07103

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07317063, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 12, 2026 · Synced Sep 10, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07317063 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →