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NCT07317063 · ClinicalTrials.gov registry record · Phase 1
A Trial to Investigate Safety and Pharmacokinetics of GRT6019, Including Food Effect, in Healthy Male Participants
A Phase 1 study, sponsored by Grünenthal.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT07317063 is a Phase 1 study that has completed, run by Grünenthal. The registered enrollment target is 18 participants.
The verdict
NCT07317063, a Phase 1 study, has completed, sponsored by Grünenthal.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
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
Interventions
- DRUG GRT6019
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2025-11-21 |
| Est. Completion | 2026-01-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07317063
The ClinicalTrials.gov registry entry for NCT07317063 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Grünenthal, which has 16 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which GRT6019 is the first listed.
NCT07317063 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07317063 about?
NCT07317063 is a clinical study titled "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 o...
What is the current status of trial NCT07317063?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2025-11-21. Estimated completion is 2026-01-06.
What interventions are being tested in trial NCT07317063?
The interventions under investigation include: GRT6019 (DRUG).
Who is sponsoring clinical trial NCT07317063?
This trial is sponsored by Grünenthal, which has 16 total clinical trials registered on ClinicalTrials.gov.
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