The purpose of this trial is to assess the safety, tolerability, and PK of 3 doses of GRT6019 in healthy male participants. This Phase I trial will be a multiple dose trial in healthy male participants with administration of GRT6019 in 3 cohorts. For each participant, the trial consists of a Screening Period of up to 28 days, a 4 week Treatment Period (including a 2-week clinic stay and 2 weeks in an outpatient setting), and a 5 week Follow-up Period.
There are 8 participants planned per cohort to ensure sufficient sample size for a reliable estimate of PK parameters.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Multiple dose (MD)
Biotrial Clinical Pharmacology Unit
Rennes, France
Number of participants with Adverse Events (AEs)
Assessment of safety and tolerability of GRT6019 following 4 weeks of treatment
Time frame: Through study completion, an average of 4 Weeks
Number of participants with Serious Adverse Events (SAEs)
Assessment of safety and tolerability of GRT6019 following 4 weeks of treatment
Time frame: Through study completion, an average of 4 Weeks
Number of participants with AEs leading to discontinuation
Assessment of safety and tolerability of GRT6019 following 4 weeks of treatment
Time frame: Through study completion, an average of 4 Weeks
Number of participants with AEs related to investigational medicinal product [IMP]
Assessment of safety and tolerability of GRT6019 following 4 weeks of treatment
Time frame: Through study completion, an average of 4 Weeks
Area under the concentration-time curve over the dosing interval (AUCtau)
Assessment of the pharmacokinetics (PK) of GRT6019 following 4 weeks of treatment, including dose proportionality assessment and investigation of steady state attainment
Time frame: Following the first dose (Day 1), then at Day 14, and after the last dose (Day 28)
Maximum observed concentration (Cmax)
Assessment of the pharmacokinetics (PK) of GRT6019 following 4 weeks of treatment, including dose proportionality assessment and investigation of steady state attainment
Time frame: Following the first dose (Day 1), then at Day 14, and after the last dose (Day 28)
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