A Phase 1 interventional study of RDN-929 and Placebo oral capsule in Healthy, sponsored by Alkermes, Inc.. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-20.
Sponsored by Alkermes, Inc. · Phase 1, Interventional, and Other
A three (3) part study to evaluate the safety, tolerability and PK of RDN-929
Part 1 (Randomized, Double Blind):
Up to 6 single ascending doses of RDN-929 are planned to be tested in 6 cohorts of 8 healthy males (Cohort 1:1 to 1:6). Within each cohort subjects will be randomly assigned to receive either a single dose of RDN-929 (6 subjects) or matched placebo (2 subjects).
Part 2 (Open):
Part 2 will consist of 2 crossover treatment periods in one cohort of 12 healthy elderly subjects (at least 3 of each gender), aged 55-80 years. The treatments will be separated by a washout period of at least 7 days. The dose selected for this part of the study will be based on the results of Part 1.
In Period 1, subjects will be randomized to receive a single dose of RDN-929 in either fasted or fed status. In Period 2, subjects will receive a single dose of RDN-929 under the alternate status.
Part 3 (Randomized, Double Blind):
Multiple ascending doses (MAD) of RDN-929 are planned to be tested in up to 4 cohorts of 8 healthy elderly subjects (at least 3 of each gender per dose level cohort), aged 55-80 years. The doses will be selected by the safety review committee (SRC) based on all available safety, tolerability and PK data and after approval by the ethics committee.
Within each cohort subjects will be randomly assigned to receive either, RDN-929 once daily (6 subjects) or matched placebo (2 subjects) once daily for 12 days. Escalation to the next higher dose level will be based upon a review of the safety and tolerability data.
Alkermes, Inc. is the lead sponsor of 82 studies on the registry; 8 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 5 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
RDN-929 single dose capsule
Drug: RDN-929
Placebo single dose capsule
Drug: Placebo oral capsule
Fed/Fast RDN-929
Drug: RDN-929 TBD dose
RDN-929 multiple dose capsules once daily for 12 days
Drug: RDN-929
placebo multiple dose capsules once daily for 10 days
Drug: Placebo oral capsule
Single dose from 2 mg to TBD
Matching placebo Single dose
Fed vs fast dose TBD based upon results of previous cohorts
Multiple dose based on results of previous cohorts
Matching placebo multiple dose
Number of subjects with adverse events
Listing and summary of AE incidence
Time frame: Screening to end of study, up to 7 weeks
Number of subjects with Physical exam findings
Listing of clinically significant changes in PE findings
Time frame: Screening to end of study, up to 7 weeks
Number of subjects with Clinical safety lab changes
Listing and change from baseline to end of study
Time frame: Screening to end of study, up to 7 weeks
Number of subjects with Systolic blood pressure changes
Listing and change from baseline to end of study
Time frame: Screening to end of study, up to 7 weeks
Number of subjects with Heart rate changes
Listing and change from baseline to end of study
Time frame: Screening to end of study, up to 7 weeks
Number of subjects with 12 Lead ECG changes
Change in 12-lead ECG parameters from baseline to end of study
Time frame: Screening to end of study, up to 7 weeks
Number of subjects with 3 Lead ECG findings
Listing of findings
Time frame: Predose to 8 hours post dose on Day 1 (Parts 1 and 2) and Days 1 and 12 (Part 3)
Number of subjects with C-SSRS changes
Listing of results
Time frame: Baseline to end of study (Part 3 only), up to 7 weeks
Number of subjects with Visual analogue scale changes
VAS for headache and nausea
Time frame: Baseline to end of study for Part 1 and 3, up to 7 weeks
Maximum observed plasma concentration, Cmax
Of RDN-929 and primary metabolite
Time frame: Predose to 48 hours post first and last dose, up to 2 days (Parts 1 and 2) and 2 weeks (Part 3)
Time to reach maximum observed plasma concentration, Tmax
Of RDN-929 and primary metabolite
Time frame: Predose to 48 hours post first and last dose, up to 2 days (Parts 1 and 2) and 2 weeks (Part 3)
Area Under the plasma concentration time curve, AUC
Of RDN-929 and primary metabolite
Time frame: Predose to 48 hours post last dose, up to 2 days (Parts 1 and 2) and 2 weeks (Part 3)
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Alkermes, Inc.