Safety, Tolerability, and Pharmacokinetics Study of Elpipodect (MK-8189) in Participants With Sch… (NCT04506905) | Clinical Trial Compass
CompletedPhase 1
Safety, Tolerability, and Pharmacokinetics Study of Elpipodect (MK-8189) in Participants With Schizophrenia and Healthy Participants (MK-8189-011)
United States63 participantsStarted 2020-08-28
Plain-language summary
This is a randomized, double-blind, 2-part clinical study of the safety, tolerability and pharmacokinetics of alternate elpipodect titration regimens. Part 1 assessed multiple dose once-daily titration regimens of elpipodect in young adult participants with schizophrenia. Part 2 assessed multiple once-daily doses of elpipodect in elderly participants with schizophrenia and healthy elderly participants.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* Has a body mass index (BMI) ≤40 kg/m2
* Has no clinically significant abnormality on 12-lead safety electrocardiogram (ECG) performed at the prestudy (screening) visit and/or prior to randomization
* Has a normal resting blood pressure (BP: systolic BP is ≥90 millimeter of mercury \[mmHg\] and ≤140 mmHg; diastolic BP is ≥60 mmHg and ≤90 mmHg) and normal resting heart rate (≥45 beats per minute \[bpm\] and ≤100 bpm) in the semirecumbent position at the prestudy (screening) visit and/or prior to randomization. Repeat evaluations may be done if the values for a participant are, per investigator discretion, minimally outside the designated range. Participants may be included if values are outside the normal range but considered not clinically significant per investigator discretion
* Participants with schizophrenia only: Meets diagnostic criteria for schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria with the onset of the first episode being no less than 2 years prior to screening and monotherapy with antipsychotics for treatment should be indicated
* Participants with schizophrenia only: Has a total Brief Psychiatric Rating Scale (BPRS) score of \<48 with a BPRS score \<4 for #10 (hostility) and #14 (uncooperativeness) at the screening visit
* Participants with schizophrenia only: Is in the nonacute phase of their illness and clinically stable for 3 months prior to …
What they're measuring
1
Part 1 & 2: Number of Participants Who Experienced an Adverse Event (AE)
Timeframe: Up to approximately 27 days
2
Part 1 & 2: Number of Participants Discontinuing Study Treatment Due to an AE