HealthyPhase 1NCT03963973
A 28 Day Parallel Group Study to Assess the Effects of RDN-929
A Phase 1 study testing RDN-929 oral capsule in people with Healthy, run by Alkermes, Inc. at 2 sites in Netherlands.
Trial summary
Eligibility will be assessed during a screening period of up to 4 weeks. Subjects will take study medication once daily up to and including Day 28. Safety, tolerability and PK will be measured at each visit. Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- RDN-929 oral capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 2 sitesNetherlands
- Study dates
- 16 May 2019to 22 Jan 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult males or postmenopausal or surgically sterile females age 55 - 85 years old.
- Healthy as determined by the Investigator, based on a medical evaluation including medical history, physical examination, neurological examination, laboratory tests and ECG recording
Who cannot join
- Any history of major psychiatric disorders, including substance use disorders, according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 1.5 times the upper limit of normal (ULN)
- A clinically significant abnormality on physical examination, neurological examination, ECG, or laboratory evaluations
- A clinically significant vital signs abnormality, as judged by the principal investigator
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Brain Research Center
Amsterdam
QPS Netherlands B.V.
Leeuwarden
About this study
Official title: A Parallel Group Study to Assess the Safety, Tolerability and Pharmacokinetic (PK) Profile of Multiple Oral Doses of RDN-929 in Healthy Older Adults
Eligibility will be assessed during a screening period of up to 4 weeks. Subjects will take study medication once daily up to and including Day 28. Safety, tolerability and PK will be measured at each visit.
- Conditions
- Healthy
- Being tested
- RDN-929 oral capsule, Placebo oral capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RDN-929 oral capsuleDrug
low, medium and high dose
Placebo oral capsuleDrug
matching placebo dose
| Study group | Role | What they receive |
|---|---|---|
| RDN-929 | Experimental | low, medium and high dose of RDN-929 capsules Receives: Drug: RDN-929 oral capsule |
| Placebo | Placebo comparator | Matching placebo capsules Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events
Screening to end of study, up to 9 weeks
Measured: up to 9 weeks
Number of subjects with Physical exam findings
Screening to end of study, up to 9 weeks
Measured: up to 9 weeks
Number of subjects with Clinical safety lab changes
Screening to end of study, up to 9 weeks
Measured: up to 9 weeks
Number of subjects with Systolic blood pressure changes
Screening to end of study, up to 9 weeks
Measured: up to 9 weeks
Number of subjects with Heart rate changes
Screening to end of study, up to 9 weeks
Measured: up to 9 weeks
Number of subjects with 12 Lead ECG changes
Screening to end of study, up to 9 weeks
Measured: up to 9 weeks
Secondary outcomes (2)
Maximum observed plasma concentration, Cmax
RDN-929 and primary metabolite ROD-1610
Measured: Day 1 to Day 28
Area Under the plasma and CSF concentration time curve, AUC
RDN-929 and primary metabolite ROD-1610
Measured: Day 1 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start16 May 2019
- Primary completion22 Jan 2020
- Study completion22 Jan 2020
Why it stopped: Participants no longer receiving intervention
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- PI, Principal investigator, QPS Holdings LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963973
- Sponsor's protocol ID
- RDN-929-103
- Status last verified
- Feb 2020
- First submitted
- 23 May 2019
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel Group Study to Assess the Safety, Tolerability and Pharmacokinetic (PK) Profile of Multiple Oral Doses of RDN-929 in Healthy Older Adults
- ClinicalTrials.gov ID
- NCT03963973
- Acronym / sponsor ID
- RDN-929-103
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Participants no longer receiving intervention
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 May 2019 (actual)
- Primary completion
- 22 Jan 2020 (actual)
- Study completion
- 22 Jan 2020 (actual)
- First posted
- 28 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Eligibility will be assessed during a screening period of up to 4 weeks. Subjects will take study medication once daily up to and including Day 28. Safety, tolerability and PK will be measured at each visit.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RDN-929 | Experimental | Drug: RDN-929 oral capsulelow, medium and high dose of RDN-929 capsules |
| Placebo | Placebo comparator | Drug: Placebo oral capsuleMatching placebo capsules |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult males or postmenopausal or surgically sterile females age 55 - 85 years old.
- Healthy as determined by the Investigator, based on a medical evaluation including medical history, physical examination, neurological examination, laboratory tests and ECG recording
Key exclusion criteria (4 listed)
- Any history of major psychiatric disorders, including substance use disorders, according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 1.5 times the upper limit of normal (ULN)
- A clinically significant abnormality on physical examination, neurological examination, ECG, or laboratory evaluations
- A clinically significant vital signs abnormality, as judged by the principal investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RDN-929 oral capsulelow, medium and high dose | Drug | RDN-929 |
| Placebo oral capsulematching placebo dose | Drug | Placebo |
Primary outcome
Number of subjects with adverse events
Time frame: up to 9 weeks
Screening to end of study, up to 9 weeks
Number of subjects with Physical exam findings
Time frame: up to 9 weeks
Screening to end of study, up to 9 weeks
Number of subjects with Clinical safety lab changes
Time frame: up to 9 weeks
Screening to end of study, up to 9 weeks
Number of subjects with Systolic blood pressure changes
Time frame: up to 9 weeks
Screening to end of study, up to 9 weeks
Number of subjects with Heart rate changes
Time frame: up to 9 weeks
Screening to end of study, up to 9 weeks
Number of subjects with 12 Lead ECG changes
Time frame: up to 9 weeks
Screening to end of study, up to 9 weeks
2 secondary outcomes
Maximum observed plasma concentration, Cmax
Time frame: Day 1 to Day 28
Area Under the plasma and CSF concentration time curve, AUC
Time frame: Day 1 to Day 28
Results and safety
The study was stopped early (reason given: Participants no longer receiving intervention). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PI principal investigator
QPS Holdings LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RDN-929 oral capsule in people with Healthy, run by Alkermes, Inc. at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Participants no longer receiving intervention). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with adverse events (time frame: up to 9 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.