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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: Completed Phase 1 study, sponsored by Grünenthal.
NCT07317063 is a Phase 1 study that has completed, run by Grünenthal. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Assessment of safety and tolerability of GRT6019 after a single oral dose
Interventions
- DRUG GRT6019
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2025-11-21 |
| Est. Completion | 2026-01-06 |
| Phase | Phase 1 |
What the finished NCT07317063 record still lists
NCT07317063 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which GRT6019 is the first listed.
NCT07317063 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07317063's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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