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HealthyPhase 1NCT03668314

Single and Multiple Ascending Dose and Food Effect PK Study in Healthy Adult and Elderly Subjects

A Phase 1 study testing RDN-929 and RDN-929 TBD dose in people with Healthy, run by Alkermes, Inc. at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A three (3) part study to evaluate the safety, tolerability and PK of RDN-929 Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
RDN-929 and RDN-929 TBD dose
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
84 participants
Where
1 siteNetherlands
Study dates
10 Oct 2018to 15 Apr 2019
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 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy as determined by the Investigator, based on a medical evaluation including medical history physical examination, neurological examination, laboratory tests and cardiac monitoring
  • Men, age 18-54 years inclusive at Screening (Part 1) or men and postmenopausal or surgically sterile women age 55-80

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.
  • Acute suicidality or history of suicidal behavior.
  • Alanine aminotransferase or aspartate aminotransferase levels greater than 1.5 times the upper limit of normal (ULN) at Screening. One retest is allowed.
  • A corrected QT interval measurement corrected according to the Fridericia rule (QTcF) > 450 msec during controlled rest at screening or between screening and first dose administration, or family history of long QT syndrome.
  • Any clinically significant abnormalities in rhythm, conduction, or morphology of the resting ECG and any abnormalities in the 12-lead ECG that, in the judgement of the Investigator or Medical Monitor, may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology or left ventricular hypertrophy.
  • A clinically significant vital signs abnormality at screening or between screening and first dose administration. This includes, but is not limited to, the following, in the supine position: (a) systolic blood pressure < 90 or >150 mmHg, (b) diastolic blood pressure <50 or > 95 mmHg, or (c) heart rate < 45 or >100 beats per minute.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • QPS Netherlands B.V.

    Groningen

Other trials in Netherlands

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of Single and Multiple Doses of Orally Administered RDN-929 in Healthy Adult and Elderly Subjects

A three (3) part study to evaluate the safety, tolerability and PK of RDN-929

Read the detailed description

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.

Conditions
Healthy
Being tested
RDN-929, Placebo oral capsule, RDN-929 TBD dose

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RDN-929Drug

    Single dose from 2 mg to TBD

  • Placebo oral capsuleDrug

    Matching placebo Single dose

  • RDN-929 TBD doseDrug

    Fed vs fast dose TBD based upon results of previous cohorts

  • RDN-929Drug

    Multiple dose based on results of previous cohorts

  • Placebo oral capsuleDrug

    Matching placebo multiple dose

Study groups in NCT03668314
Study groupRoleWhat they receive
Cohort 1:1 - 1:6 RDN-929ExperimentalRDN-929 single dose capsule
Receives: Drug: RDN-929
Cohort 1:1 - 1:6 placeboPlacebo comparatorPlacebo single dose capsule
Receives: Drug: Placebo oral capsule
Cohort 2:1ExperimentalFed/Fast RDN-929
Receives: Drug: RDN-929 TBD dose
Cohort 3:1- 3:4 RDN-929ExperimentalRDN-929 multiple dose capsules once daily for 12 days
Receives: Drug: RDN-929
Cohort 3:1- 3:4 placeboPlacebo comparatorplacebo multiple dose capsules once daily for 10 days
Receives: Drug: Placebo oral capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of subjects with adverse events

    Listing and summary of AE incidence

    Measured: Screening to end of study, up to 7 weeks

  2. Number of subjects with Physical exam findings

    Listing of clinically significant changes in PE findings

    Measured: Screening to end of study, up to 7 weeks

  3. Number of subjects with Clinical safety lab changes

    Listing and change from baseline to end of study

    Measured: Screening to end of study, up to 7 weeks

  4. Number of subjects with Systolic blood pressure changes

    Listing and change from baseline to end of study

    Measured: Screening to end of study, up to 7 weeks

  5. Number of subjects with Heart rate changes

    Listing and change from baseline to end of study

    Measured: Screening to end of study, up to 7 weeks

  6. Number of subjects with 12 Lead ECG changes

    Change in 12-lead ECG parameters from baseline to end of study

    Measured: Screening to end of study, up to 7 weeks

  7. Number of subjects with 3 Lead ECG findings

    Listing of findings

    Measured: Predose to 8 hours post dose on Day 1 (Parts 1 and 2) and Days 1 and 12 (Part 3)

  8. Number of subjects with C-SSRS changes

    Listing of results

    Measured: Baseline to end of study (Part 3 only), up to 7 weeks

  9. Number of subjects with Visual analogue scale changes

    VAS for headache and nausea

    Measured: Baseline to end of study for Part 1 and 3, up to 7 weeks

Secondary outcomes (3)

  1. Maximum observed plasma concentration, Cmax

    Of RDN-929 and primary metabolite

    Measured: Predose to 48 hours post first and last dose, up to 2 days (Parts 1 and 2) and 2 weeks (Part 3)

  2. Time to reach maximum observed plasma concentration, Tmax

    Of RDN-929 and primary metabolite

    Measured: Predose to 48 hours post first and last dose, up to 2 days (Parts 1 and 2) and 2 weeks (Part 3)

  3. Area Under the plasma concentration time curve, AUC

    Of RDN-929 and primary metabolite

    Measured: Predose to 48 hours post last dose, up to 2 days (Parts 1 and 2) and 2 weeks (Part 3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2018
  2. Study start10 Oct 2018
  3. Primary completion15 Apr 2019
  4. Study completion15 Apr 2019

Resources

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
Model description
Parts 1 and 3 are parallel designs with escalating doses within each part. Part 2 is a FE cross-over study
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03668314
Sponsor's protocol ID
RDN-929-101
Status last verified
Feb 2020
First submitted
6 Sep 2018
Last updated
20 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RDN-929 and RDN-929 TBD dose in people with Healthy, run by Alkermes, Inc. at 1 site 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 6 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: finished, 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 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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: Screening to end of study, up to 7 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03668314.

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.

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Clinical Trial NCT03668314 | AzTrials