Human Abuse PotentialPhase 1NCT03799900
Assessment of Abuse Potential of Rapastinel in Humans
A Phase 1 study testing Rapastinel and Ketamine in people with Human Abuse Potential, run by Naurex, Inc, an affiliate of Allergan plc at 1 site in United States.
Trial summary
Based on the pharmacological class of rapastinel, this study will be conducted to evaluate the abuse potential of single doses of rapastinel as compared with ketamine, a NMDAR antagonist that is a Schedule III dissociative anesthetic, and placebo in recreational polydrug users. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Abuse Potential
- What is being tested?
- Rapastinel and Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 29 Mar 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant must be a current recreational polydrug user
- Have a supine systolic blood pressure (BP) ≥ 95 mm Hg and ≤ 145 mg Hg, or supine diastolic BP ≥ 50 mm Hg and ≤ 90 mm Hg at the Screening Visit.
- Have negative test results for benzoylecgonine (cocaine), methadone, barbiturates, amphetamines, benzodiazepines, alcohol, oxycodone and other opioids, and phencyclidine at any admission
- Able, as assessed by the investigator, and willing to follow study instructions and likely to complete all required study visits
Who cannot join
- Evidence of drug or alcohol dependence (excluding nicotine and caffeine) within the past 2 years
- Suicidal risk based on the opinion of the principal investigator (or appropriately trained designee)
- History of violent or psychotic behavior when taking psychedelic drugs, or unwilling to take a drug that might alter perception in a controlled setting
- Have taken or require concomitant treatment with any CNS depressants, or cannot safely discontinue these medications within 14 days (or 5 half-lives, whichever is longer) before study treatment administration
- Previously participated in an investigational study of rapastinel.
- Participation in any other clinical investigation using an experimental drug within 30 days, 5 half-lives or twice the duration of the biological effect of the study treatment (whichever is longer), prior to study treatment administration or is concurrently enrolled in any clinical trial, judged not to be scientifically or medically compatible with this study
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- Consumption of alcohol within 72 hours before administration of study treatment
- Breastfeeding
- Unable to refrain from consuming caffeine or xanthine-containing compounds such as tea, coffee, soft drinks, energy sports drinks or chocolate (more than 48 oz/day) from 48 hours before administration of study treatment.
- Have consumed dietary supplements or other foods or beverages that may affect various drug metabolizing enzymes and transporters (eg, grapefruit, grapefruit juice, grapefruit-containing beverages), vegetables from the mustard green family (eg, kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, mustard), and charbroiled meats within 14 days prior to dosing or unable to refrain from consumption during the study.
- The ability to tolerate IV ketamine as judged by the Investigator, based on available safety data, as well as pharmacodynamic data.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vince and Associates Clinical Research Inc
Overland Park, Kansas, 66212
About this study
Official title: A Two-part, Single-dose, Randomized, Double-blind, Placebo and Active-Controlled Crossover Study to Evaluate the Abuse Potential of Rapastinel in Healthy, Non-dependent, Adult Recreational Polydrug Users
Based on the pharmacological class of rapastinel, this study will be conducted to evaluate the abuse potential of single doses of rapastinel as compared with ketamine, a NMDAR antagonist that is a Schedule III dissociative anesthetic, and placebo in recreational polydrug users.
- Conditions
- Human Abuse Potential
- Being tested
- Rapastinel, Ketamine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RapastinelDrug
During the Treatment Phase in Part 2, participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner.
KetamineDrug
Part 1
Part 2, Qualification Phase:
Participants will be administered single IV doses of ketamine and placebo in a randomized crossover manner
Part 2, Treatment Phase:
Participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner.
PlaceboDrug
Part 1
Part 2, Qualification Phase:
Participants will be administered single IV doses of ketamine and placebo in a randomized crossover manner
Part 2, Treatment Phase:
Participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner.
| Study group | Role | What they receive |
|---|---|---|
| Part 1, Cohort 1: Ketamine Low Dose | Experimental | Some participants will be administered a single IV dose of ketamine on Day 1. Receives: Drug: Ketamine |
| Part 1, Cohort 1: Placebo | Placebo comparator | Some participants will be administered a single IV dose of placebo on Day 1. Receives: Drug: Placebo |
| Part 1, Cohort 2: Ketamine Medium Dose | Experimental | Some participants will be administered a single IV dose of ketamine on Day 1. Receives: Drug: Ketamine |
| Part 1, Cohort 2: Placebo | Placebo comparator | Some participants will be administered a single IV dose of placebo on Day 1. Receives: Drug: Placebo |
| Part 1, Cohort 3 (Optional): Ketamine High Dose | Experimental | Optional: some participants will be administered a single IV dose of ketamine on Day 1. Receives: Drug: Ketamine |
| Part 1, Cohort 3 (Optional): Placebo | Placebo comparator | Optional: some participants will be administered a single IV dose of placebo on Day 1. Receives: Drug: Placebo |
| Part 2, Qualification Phase: Ketamine | Experimental | Participants will receive IV ketamine on Day 1 and placebo on Day 2 in a randomized crossover manner. Receives: Drug: Ketamine |
| Part 2, Qualification Phase: Placebo | Placebo comparator | Participants will receive IV ketamine on Day 2 and placebo on Day 1 in a randomized crossover manner. Receives: Drug: Placebo |
| Part 2, Treatment Phase: Rapastinel Low Dose | Experimental | Participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner. Receives: Drug: Rapastinel |
| Part 2, Treatment Phase: Rapastinel Medium Dose | Experimental | Participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner. Receives: Drug: Rapastinel |
| Part 2, Treatment Phase: Rapastinel High Dose | Experimental | Participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner. Receives: Drug: Rapastinel |
| Part 2, Treatment Phase: Ketamine | Active comparator | Participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner. Receives: Drug: Ketamine |
| Part 2, Treatment Phase: Placebo | Placebo comparator | Participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum effect (Emax) for "At this Moment" Drug Liking visual analog scale (VAS).
The drug liking VAS measures the participant's liking for the drug and is scored from 0 to 100, with 0 reflecting "Strong disliking" and 100 reflecting "Strong liking".
Measured: Treatment Phase: Pre-dose and up to 24 hours post-dose
Secondary outcomes (10)
Maximum effect (Emax)
Measured: Treatment Phase: Pre-dose and up to 24 hours post-dose
Minimum effect (Emin)
Measured: Treatment Phase: Pre-dose and up to 24 hours post-dose
Time to Emax (TEmax)
Measured: Treatment Phase: Pre-dose and up to 24 hours post-dose
Time to Emin (TEmin)
Measured: Treatment Phase: Pre-dose and up to 24 hours post-dose
Time averaged area under the effect curve (TA_AUE)
Measured: Treatment Phase: Hour 0 and up to 24 Hours post-dose
Maximum plasma drug concentration (Cmax)
Measured: Treatment Phase: Pre-dose and up to 24 hours post-dose
Area under the plasma concentration versus time curve from time 0 to the last quantifiable concentration (AUClast)
Measured: Treatment Phase: Pre-dose and up to 24 hours post-dose
Adverse events
Measured: Part 1: 6 weeks, Part 2: 9 weeks
Proportion of abnormal electrocardiograms
Measured: Part 1: 6 weeks, Part 2: 9 weeks
Columbia-Suicide Severity Rating Scale
The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 (least severe) to 5 (most severe).
Measured: Part 1: 6 weeks, Part 2: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start1 Nov 2018
- Primary completion24 Mar 2019
- Study completion29 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Abuse PotentialStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naurex, Inc, an affiliate of Allergan plc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sheng Fang Su, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799900
- Sponsor's protocol ID
- RAP-PK-12
- Status last verified
- May 2019
- First submitted
- 15 Nov 2018
- Last updated
- 16 May 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-part, Single-dose, Randomized, Double-blind, Placebo and Active-Controlled Crossover Study to Evaluate the Abuse Potential of Rapastinel in Healthy, Non-dependent, Adult Recreational Polydrug Users
- ClinicalTrials.gov ID
- NCT03799900
- Acronym / sponsor ID
- RAP-PK-12
- Conditions
- Human Abuse Potential
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Naurex, Inc, an affiliate of Allergan plcIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 24 Mar 2019 (actual)
- Study completion
- 29 Mar 2019 (actual)
- First posted
- 10 Jan 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.
Based on the pharmacological class of rapastinel, this study will be conducted to evaluate the abuse potential of single doses of rapastinel as compared with ketamine, a NMDAR antagonist that is a Schedule III dissociative anesthetic, and placebo in recreational polydrug users.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Part 1, Cohort 1: Ketamine Low Dose | Experimental | Drug: KetamineSome participants will be administered a single IV dose of ketamine on Day 1. |
| Part 1, Cohort 1: Placebo | Placebo comparator | Drug: PlaceboSome participants will be administered a single IV dose of placebo on Day 1. |
| Part 1, Cohort 2: Ketamine Medium Dose | Experimental | Drug: KetamineSome participants will be administered a single IV dose of ketamine on Day 1. |
| Part 1, Cohort 2: Placebo | Placebo comparator | Drug: PlaceboSome participants will be administered a single IV dose of placebo on Day 1. |
| Part 1, Cohort 3 (Optional): Ketamine High Dose | Experimental | Drug: KetamineOptional: some participants will be administered a single IV dose of ketamine on Day 1. |
| Part 1, Cohort 3 (Optional): Placebo | Placebo comparator | Drug: PlaceboOptional: some participants will be administered a single IV dose of placebo on Day 1. |
| Part 2, Qualification Phase: Ketamine | Experimental | Drug: KetamineParticipants will receive IV ketamine on Day 1 and placebo on Day 2 in a randomized crossover manner. |
| Part 2, Qualification Phase: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive IV ketamine on Day 2 and placebo on Day 1 in a randomized crossover manner. |
| Part 2, Treatment Phase: Rapastinel Low Dose | Experimental | Drug: RapastinelParticipants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner. |
| Part 2, Treatment Phase: Rapastinel Medium Dose | Experimental | Drug: RapastinelParticipants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner. |
| Part 2, Treatment Phase: Rapastinel High Dose | Experimental | Drug: RapastinelParticipants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner. |
| Part 2, Treatment Phase: Ketamine | Active comparator | Drug: KetamineParticipants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner. |
| Part 2, Treatment Phase: Placebo | Placebo comparator | Drug: PlaceboParticipants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participant must be a current recreational polydrug user
- Have a supine systolic blood pressure (BP) ≥ 95 mm Hg and ≤ 145 mg Hg, or supine diastolic BP ≥ 50 mm Hg and ≤ 90 mm Hg at the Screening Visit.
- Have negative test results for benzoylecgonine (cocaine), methadone, barbiturates, amphetamines, benzodiazepines, alcohol, oxycodone and other opioids, and phencyclidine at any admission
- Able, as assessed by the investigator, and willing to follow study instructions and likely to complete all required study visits
Key exclusion criteria (11 listed)
- Evidence of drug or alcohol dependence (excluding nicotine and caffeine) within the past 2 years
- Suicidal risk based on the opinion of the principal investigator (or appropriately trained designee)
- History of violent or psychotic behavior when taking psychedelic drugs, or unwilling to take a drug that might alter perception in a controlled setting
- Have taken or require concomitant treatment with any CNS depressants, or cannot safely discontinue these medications within 14 days (or 5 half-lives, whichever is longer) before study treatment administration
- Previously participated in an investigational study of rapastinel.
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 |
|---|---|---|
| RapastinelDuring the Treatment Phase in Part 2, participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner. | Drug | Part 2, Treatment Phase: Rapastinel High Dose, Part 2, Treatment Phase: Rapastinel Low Dose, Part 2, Treatment Phase: Rapastinel Medium Dose |
| KetaminePart 1 Part 2, Qualification Phase: Participants will be administered single IV doses of ketamine and placebo in a randomized crossover manner Part 2, Treatment Phase: Participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner. | Drug | Part 1, Cohort 1: Ketamine Low Dose, Part 1, Cohort 2: Ketamine Medium Dose, Part 1, Cohort 3 (Optional): Ketamine High Dose, Part 2, Qualification Phase: Ketamine, Part 2, Treatment Phase: Ketamine |
| PlaceboPart 1 Part 2, Qualification Phase: Participants will be administered single IV doses of ketamine and placebo in a randomized crossover manner Part 2, Treatment Phase: Participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner. | Drug | Part 1, Cohort 1: Placebo, Part 1, Cohort 2: Placebo, Part 1, Cohort 3 (Optional): Placebo, Part 2, Qualification Phase: Placebo, Part 2, Treatment Phase: Placebo |
Primary outcome
Maximum effect (Emax) for "At this Moment" Drug Liking visual analog scale (VAS).
Time frame: Treatment Phase: Pre-dose and up to 24 hours post-dose
The drug liking VAS measures the participant's liking for the drug and is scored from 0 to 100, with 0 reflecting "Strong disliking" and 100 reflecting "Strong liking".
10 secondary outcomes
Maximum effect (Emax)
Time frame: Treatment Phase: Pre-dose and up to 24 hours post-dose
Minimum effect (Emin)
Time frame: Treatment Phase: Pre-dose and up to 24 hours post-dose
Time to Emax (TEmax)
Time frame: Treatment Phase: Pre-dose and up to 24 hours post-dose
Time to Emin (TEmin)
Time frame: Treatment Phase: Pre-dose and up to 24 hours post-dose
Time averaged area under the effect curve (TA_AUE)
Time frame: Treatment Phase: Hour 0 and up to 24 Hours post-dose
Maximum plasma drug concentration (Cmax)
Time frame: Treatment Phase: Pre-dose and up to 24 hours post-dose
Area under the plasma concentration versus time curve from time 0 to the last quantifiable concentration (AUClast)
Time frame: Treatment Phase: Pre-dose and up to 24 hours post-dose
Adverse events
Time frame: Part 1: 6 weeks, Part 2: 9 weeks
Proportion of abnormal electrocardiograms
Time frame: Part 1: 6 weeks, Part 2: 9 weeks
Columbia-Suicide Severity Rating Scale
Time frame: Part 1: 6 weeks, Part 2: 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2019.
- Individual participant dataSharing planned: Undecided
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.
Sheng Fang Su study director
Allergan
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 Rapastinel and Ketamine in people with Human Abuse Potential, run by Naurex, Inc, an affiliate of Allergan plc at 1 site in United States.
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 4 inclusion and 11 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 16 May 2019. 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 United States. 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?
Maximum effect (Emax) for "At this Moment" Drug Liking visual analog scale (VAS). (time frame: Treatment Phase: Pre-dose and up to 24 hours post-dose). 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 16 May 2019.