Skip to main content
OpenTrials
Completed

NCT Number: NCT07317063

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Duchenne Muscular Dystrophy (DMD) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy, Duchenne Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Biotrial, Inc

Newark, New Jersey, 07103, United States

About this study

Cohort 1 and Cohort 2 will be dosed in parallel:

  • Cohort 1 (n = 9): single dose of GRT6019 in participants in a fed state
  • Cohort 2 (n = 9): single dose of GRT6019 in participants in a fasted state

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Main inclusion Criteria:

  • The participant must be able to give signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  • Participants must sign the ICF before any trial-related assessments.
  • The participant is in good health as determined by the medical history, physical examination, 12-lead Electrocardiogram (ECG), vital signs (heart rate [HR], respiratory rate [RR], systolic and diastolic blood pressure [BP]), body temperature, and clinical laboratory parameters (clinical chemistry, hematology, coagulation, and urinalysis) without clinically relevant (per investigator judgement) deviations from reference ranges unless further specified in the exclusion criteria.

Main exclusion Criteria:

  • Any disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, comparator, rescue medication, or any ingredients therein, or may affect the interpretation of the results, or may render the patient at high risk from treatment complications/ participation in the study unsafe.
  • Major surgical procedure, within 3 months prior to ICF signing, or anticipation of need for a major surgical procedure during the trial.
  • Clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, or immunological disorder(s) as determined by the investigator.
  • Any medication, including herbal remedies or over-the-counter medication within 2 weeks before screening into this trial and anticipated use during the trial.
  • Concurrent enrollment in another clinical trial unless it is an observational (non-interventional) clinical trial or during the Follow-up Period of an interventional trial.
  • Recent participation in another clinical trial with an IMP administered within 30 days before Day 1 OR within 5 times the elimination half-life of the IMP, whichever is longer.

Treatment and study plan

GRT6019

Drug

Single Dose

Other names: Study drug

Primary outcomes

  1. Number of participants with Adverse Events

    Time frame: Through study completion, an average of 7 Weeks

    Assessment of safety and tolerability of GRT6019 after a single oral dose

  2. Number of participants with serious Adverse Events

    Time frame: Through study completion, an average of 7 Weeks

    Assessment of safety and tolerability of GRT6019 after a single oral dose

  3. Number of participants with Adverse Events leading to discontinuation

    Time frame: Through study completion, an average of 7 Weeks

    Assessment of safety and tolerability of GRT6019 after a single oral dose

  4. Number of participants with Adverse Events related with GRT6019

    Time frame: Through study completion, an average of 7 Weeks

    Assessment of safety and tolerability of GRT6019 after a single oral dose

Secondary outcomes

  1. Area under the concentration-time curve from pre-dose (time 0) to the time of the last quantifiable concentration (AUC0-t)

    Time frame: From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.

    The total amount of the study drug in the blood from the time it is taken until the last time a measurable level of the drug is found.

    Assessment of the PK of GRT6019 following a single dose under fasted and fed conditions.

  2. Area under the concentration-time curve from pre-dose (time 0) extrapolated to infinite time (AUC0-inf )

    Time frame: From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.

    The total amount of the study drug in the blood from the time it is taken until it has completely left the body.

    Assessment of the PK of GRT6019 following a single dose under fasted and fed conditions.

  3. Maximum plasma concentration (Cmax)

    Time frame: From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.

    The maximum amount of the study drug measured in the blood after taking the dose.

    Assessment of the PK of GRT6019 following a single dose under fasted and fed conditions.

  4. Time of maximum plasma concentration (Tmax)

    Time frame: From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.

    The time it takes to reach the highest concentration of the study drug in the blood after dosing.

    Assessment of the PK of GRT6019 following a single dose under fasted and fed conditions.

  5. Lag-time observed from dosing to the time point prior to that of the first quantifiable plasma concentration (Tlag). Assessment of the PK of GRT6019 following a single oral dose of the pediatric formulation under fasted and fed conditions.

    Time frame: From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.

    The time between when the study drug is taken and when it first becomes measurable in the blood.

    Assessment of the PK of GRT6019 following a single dose under fasted and fed conditions.

  6. Terminal elimination half life (T₁/₂)

    Time frame: From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.

    The time it takes for the amount of study drug in the blood to reduce by half after reaching its peak level.

    Assessment of the PK of GRT6019 following a single dose under fasted and fed conditions.

  7. Total body oral clearance (CL/F)

    Time frame: From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.

    The amount of blood completely cleared of thestudy drug (and metabolite) per unit of time, taking into account how much of the drug is absorbed into the body.

    Assessment of the PK of GRT6019 following a single dose under fasted and fed conditions.

  8. Apparent volume of distribution (V/F)

    Time frame: From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.

    An estimate of how widely the study drug spreads through the body's tissues after it is absorbed.

    Assessment of the PK of GRT6019 following a single dose under fasted and fed conditions.

  9. Ratio of the geometric mean of AUC0-t

    Time frame: From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.

    Assessment of the effect of food (fed and fasted state) on the PK of GRT6019 following a single dose.

  10. Ratio of the geometric mean of AUC0-inf

    Time frame: From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.

    Assessment of the effect of food (fed and fasted state) on the PK of GRT6019 following a single dose.

  11. Ratio of the geometric mean of Cmax

    Time frame: From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.

    Assessment of the effect of food (fed and fasted state) on the PK of GRT6019 following a single dose.

Sponsors and collaborators

Lead sponsor

Grünenthal GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 5, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.