Central Nervous System DiseasesPhase 1NCT05019105
Phase 1 ALKS 1140 in Healthy Adults
A Phase 1 study testing ALKS 1140 in people with Central Nervous System Diseases, run by Alkermes, Inc. at 1 site in Australia.
Trial summary
To evaluate the safety and tolerability of ALKS 1140 in healthy adult subjects Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Central Nervous System Diseases
- What is being tested?
- ALKS 1140
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- 13 Oct 2021to 23 Aug 2022
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) ≥18 and <30 kg/m2
Who cannot join
- Clinically significant illness or disease including significant cardiac, gastrointestinal (stomach)
- Subjects who have known allergic reactions to food or medications
- Women of childbearing potential
- Any clinically significant lifetime history of suicidal behavior or ideation (thoughts)
- Subject had lymphoma, leukemia, or any malignancy within the past 5 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Escalating Doses of ALKS 1140 With a Pilot Evaluation of Food Effect in Healthy Adult Subjects
To evaluate the safety and tolerability of ALKS 1140 in healthy adult subjects
- Conditions
- Central Nervous System Diseases
- Being tested
- Placebo, ALKS 1140
- Medical subject headings
- Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Oral matching placebo
ALKS 1140Drug
Active oral dose of ALKS 1140
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo administered orally Receives: Drug: Placebo |
| ALKS 1140 | Active comparator | Up to 8 single ascending doses of ALKS 1140 and 4 multiple ascending doses administered orally Receives: Drug: ALKS 1140 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events
Measured: Up to 28 days
Change in Columbia-Suicide Severity Rating Scale (C-SSRS)
Change in C-SSRS measured in Multiple-Ascending Dose subjects only
Measured: Up to 28 days
12-lead safety ECG results
ECG parameters (Heart Rate, RR, PR, QRS, QT, QTcF, T wave) will be analysed using descriptive summary statistics (mean, standard deviation, median, minimum, and maximum for continuous variables) and as a change from baseline by dose level and treatment group. For the QT interval assessment, clinically abnormal ECG results for QTcF will be tabulated by protocol-specified millisecond range categories by dose and treatment group. Potentially clinically significant findings will be summarized by dose and treatment group.
Measured: Up to 28 days
Secondary outcomes (9)
Maximum plasma concentration (Cmax) for ALKS 1140
Measured: Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29
Time to Cmax (Tmax)
Measured: Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29
Half-life (t1/2) of ALKS 1140
Measured: Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours
Time until first quantifiable concentration (tlag)
Measured: Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29
Area under the concentration-time curve (AUC)
Measured: Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29
Apparent volume of distribution at terminal phase (Vz/F)
Measured: Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29
Apparent total clearance following oral administration (CL/F)
Measured: Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and Day 29
Change from baseline in QTcF (Fridericia method) interval in response to treatment (Holter monitoring)
Measured: Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and Day 29
Accumulation Index (RA)
Measured: Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start13 Oct 2021
- Primary completion23 Aug 2022
- Study completion23 Aug 2022
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System DiseasesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019105
- Sponsor's protocol ID
- ALKS 1140-001
- Status last verified
- Aug 2022
- First submitted
- 16 Aug 2021
- Last updated
- 2 Sep 2022
- 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 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Escalating Doses of ALKS 1140 With a Pilot Evaluation of Food Effect in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05019105
- Acronym / sponsor ID
- ALKS 1140-001
- Conditions
- Central Nervous System Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Oct 2021 (actual)
- Primary completion
- 23 Aug 2022 (actual)
- Study completion
- 23 Aug 2022 (actual)
- First posted
- 24 Aug 2021 (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.
To evaluate the safety and tolerability of ALKS 1140 in healthy adult subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered orally |
| ALKS 1140 | Active comparator | Drug: ALKS 1140Up to 8 single ascending doses of ALKS 1140 and 4 multiple ascending doses administered orally |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body mass index (BMI) ≥18 and <30 kg/m2
Key exclusion criteria (5 listed)
- Clinically significant illness or disease including significant cardiac, gastrointestinal (stomach)
- Subjects who have known allergic reactions to food or medications
- Women of childbearing potential
- Any clinically significant lifetime history of suicidal behavior or ideation (thoughts)
- Subject had lymphoma, leukemia, or any malignancy within the past 5 years
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 |
|---|---|---|
| PlaceboOral matching placebo | Drug | Placebo |
| ALKS 1140Active oral dose of ALKS 1140 | Drug | ALKS 1140 |
Primary outcome
Incidence of treatment-emergent adverse events
Time frame: Up to 28 days
Change in Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to 28 days
Change in C-SSRS measured in Multiple-Ascending Dose subjects only
12-lead safety ECG results
Time frame: Up to 28 days
ECG parameters (Heart Rate, RR, PR, QRS, QT, QTcF, T wave) will be analysed using descriptive summary statistics (mean, standard deviation, median, minimum, and maximum for continuous variables) and as a change from baseline by dose level and treatment group. For the QT interval assessment, clinically abnormal ECG results for QTcF will be tabulated by protocol-specified millisecond range categories by dose and treatment group. Potentially clinically significant findings will be summarized by dose and treatment group.
9 secondary outcomes
Maximum plasma concentration (Cmax) for ALKS 1140
Time frame: Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29
Time to Cmax (Tmax)
Time frame: Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29
Half-life (t1/2) of ALKS 1140
Time frame: Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours
Time until first quantifiable concentration (tlag)
Time frame: Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29
Area under the concentration-time curve (AUC)
Time frame: Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29
Apparent volume of distribution at terminal phase (Vz/F)
Time frame: Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29
Apparent total clearance following oral administration (CL/F)
Time frame: Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and Day 29
Change from baseline in QTcF (Fridericia method) interval in response to treatment (Holter monitoring)
Time frame: Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and Day 29
Accumulation Index (RA)
Time frame: Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and Day 29
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALKS 1140 in people with Central Nervous System Diseases, run by Alkermes, Inc. at 1 site in Australia.
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 1 inclusion and 5 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 2 Sep 2022. 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 Australia. 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: Sponsor Decision). 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?
Incidence of treatment-emergent adverse events (time frame: Up to 28 days). The study lists 3 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 2 Sep 2022.