An adaptive, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to examine the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of RGH-338 in healthy male volunteers.
- Conditions
- Autism spectrum disorder10012562
- Registration Number
- NL-OMON55280
- Lead Sponsor
- Gedeon Richter Plc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
1. Healthy male volunteers.
2. Aged 18*45 years (inclusive).
3. A body mass index (Quetelet index) in the range 18.5 * 30.0 kg/m2
(inclusive) as measured at screening.
1. Clinically relevant abnormal history, physical finding,12-lead safety ECG,
or laboratory value at screening that could interfere with the objectives of
the trial or the safety of the volunteer.
2. Family history of seizures or a clinically significant psychiatric disorder.
5. Risk of suicide, as judged by an Investigator, based upon available source
information * including the C-SSRS or family history of suicide * indicating
current suicidal ideation or a history of active suicidal ideation or suicide
attempts.
28. Positive SARS-CoV-2 PCR analysis prior to first dosing.
29. Any current, clinically significant, known medical condition in particular
any existing conditions that would affect sensitivity to cold (such as
atherosclerosis, Raynaud*s disease, urticaria, hypothyroidism) or pain (such as
disease that causes pain, hypesthesia, hyperalgesia, allodynia, paraesthesia,
neuropathy).
30. Participants indicating pain tests intolerable at screening. Participants
achieving tolerance at >80% of maximum input intensity for cold pressor and
electrical pain tests are to be excluded. If pressure pain test tolerance is
>80% of maximum input intensity they may be enrolled as per PI judgement.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Tolerability / safety endpoints<br /><br>Safety: vital signs, 12-lead safety ECG, physical examination, laboratory<br /><br>safety tests (routine haematology, biochemistry, urinalysis and coagulation),<br /><br>C-SSRS, concomitant medication and adverse events.<br /><br>Tolerability: adverse events.<br /><br>Pharmacokinetic endpoints<br /><br>The following pharmacokinetic parameters of RGH-338 will be determined as<br /><br>applicable<br /><br>Part 1: Cmax, Tmax, AUC0-t, AUC0-24, AUCinf, MRT, CL/F, VZ/F, t1/2.<br /><br>Part 2: Cmax, Tmax, AUC0-t, AUC0-24, AUCinf, MRT, CL/F, VZ/F, t1/2<br /><br>Part 3: For the first day of multiple dosing: Cmax, Tmax and AUCtau. For the<br /><br>last day of multiple dosing: Cmax, Tmax, Cmin, Cavg, AUC0-t, AUCtau, AUCinf,<br /><br>MRT, CL/F, V/F, t1/2, Fluctuation%, Rac.<br /><br>Renal clearance and the cumulative amount of RGH-338 excreted in urine will be<br /><br>determined, if applicable. </p><br>
- Secondary Outcome Measures
Name Time Method