Schizophrenia or Schizoaffective DisorderPhase 1MADNCT02504476
Multiple Ascending Dose Study on Safety, Tolerability, and Pharmacokinetics of AMG 581 in Healthy Subjects or Subjects With Schizophrenia or Schizoaffective
A Phase 1 study testing AMG 581 and Midazolam in people with Schizophrenia or Schizoaffective Disorder, run by Amgen at 2 sites in United States.
Trial summary
The purpose of this study is to find out the time it takes to absorb, distribute, breakdown and remove the drug from the body in healthy participants and subjects with schizophrenia and whether it causes any side effects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia or Schizoaffective Disorder
- What is being tested?
- AMG 581 and Midazolam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2015to Feb 2016
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provided informed consent prior to initiation of any study-specific activities/procedures; -male or female subjects should be between the ages of 18 and 45 years (18-55 years for subjects with schizophrenia);-non-nicotine or non-tobacco (healthy subjects only); - no history of relevant medical disorders; - BMI ≥ 18.0; - females of non-reproductive potential; - males practicing effective birth control; - avoid tanning/direct sunlight; - schizophrenia or schizoaffective disorder; PANSS score ≤ 4 points on following items (i.e. conceptual disorganization, hallucinatory behavior, excitement, suspiciousness/persecution, hostility, depression, anxiety, disorientation, uncooperativeness, disturbance of volition, and poor impulse control) / total score ≤ 80 points
Who cannot join
- females lactating/breastfeeding; pregnant partners of male subjects; essential tremor or gait disturbance; - history of hereditary shorten QT syndrome; - malignancy or tumor (other than skin cancers); - history of GI disease that could interfere with absorption; - QTc ≥ 450 msec or ≤ 380 msec; - HbA1c ≥ 7%;
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Research Site
Glendale, California, 91206
Parexel
Glendale, California
About this study
Official title: A Phase I, Randomized, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AMG 581 in Healthy Subjects or Subjects With Schizophrenia or Schizoaffective Disorder on Antipsychotic Medication
The purpose of this study is to find out the time it takes to absorb, distribute, breakdown and remove the drug from the body in healthy participants and subjects with schizophrenia and whether it causes any side effects.
Read the detailed description
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic profile of ascending multiple oral doses of AMG 581 in healthy subjects or subjects with schizophrenia or schizoaffective disorder on antipsychotic medication. The study will also assess the effects of AMG 581 on midazolam PK in healthy subjects or subjects with schizophrenia or schizoaffective disorder on antipsychotic medication.
- Being tested
- AMG 581, Placebo, Midazolam
- Keywords
- Schizophrenia or Schizoaffective Disorder
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 581Drug
Active drug
PlaceboDrug
Placebo
MidazolamDrug
Interaction
| Study group | Role | What they receive |
|---|---|---|
| AMG 581 - Dose 1 | Active comparator | Not described Receives: Drug: AMG 581 |
| AMG 581 - Dose 2 | Active comparator | Not described Receives: Drug: AMG 581 |
| AMG 581 - Dose 3 | Active comparator | Not described Receives: Drug: AMG 581 |
| AMG 581 - Dose 4 | Active comparator | Not described Receives: Drug: AMG 581 |
| Placebo - Dose 1 | Placebo comparator | Not described Receives: Drug: AMG 581; Drug: Placebo |
| Placebo - Dose 2 | Placebo comparator | Not described Receives: Drug: Placebo |
| Placebo - Dose 3 | Placebo comparator | Not described Receives: Drug: Placebo |
| Placebo - Dose 4 | Placebo comparator | Not described Receives: Drug: Placebo |
| AMG 581/Midazolam - Drug Interaction | Other | Not described Receives: Drug: AMG 581; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reported treatment-emergent adverse events
Number and percent of subjects experiencing adverse events
Measured: 39 days
Changes in systolic/diastolic blood pressure
Summaries over time and/or changes from baseline over time in systolic and/or diastolic blood pressure
Measured: 39 days
Changes in heart rate
Summaries over time and/or changes from baseline over time in heart rate
Measured: 39 days
Changes in respiratory rate
Summaries over time and/or changes from baseline over time in respiratory rate
Measured: 39 days
Changes in temperature
Summaries over time and/or changes from baseline over time in temperature
Measured: 39 days
Changes in ECGs
Summaries over time and/or changes from baseline over time in ECGs
Measured: 39 days
Maximum change from baseline in QTc in ECGs and number and percentage of subjects with maximum changes exceeding prespecified limits in each group
Subjects' maximum change from baseline in QTc and the number and percentage of subjects in each group
Measured: 39 days
Maximum post-baseline QTc values and number and percentage of subjects with maximum post-baseline QTc values exceeding prespecified limits in each group
Subjects' maximum post-baseline values and the number and percentage of subjects in each group
Measured: 39 days
Scores at each study visit for Simpson Angus Scale (SAS)
Summaries over time and/or changes from baseline over time in changes in Simpson Angus Scale (SAS) score
Measured: 39 days
Scores at each study visit for Barnes Akathisia Rating Scale (BARS)
Summaries over time and/or changes from baseline over time in in Barnes Akathisia Rating Scale (BARS) score
Measured: 39 days
Subject incidence of treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Subject incidence of treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) summarized by cohort
Measured: 39 days
Secondary outcomes (4)
Compare PK parameter (Cmax) between Day 1 and Day 18
Compare PK parameter (Cmax) between Day 1 and Day 18
Measured: 18 days
Compare PK parameter (AUC) between Day 1 and Day 18
Compare PK parameter (AUC) between Day 1 and Day 18
Measured: 18 days
Compare PK parameter (tmax) Compare PK parameter (tmax) between Day 1 and Day 18
Compare PK parameter (tmax) Compare PK parameter (tmax) between Day 1 and Day 18
Measured: 18 days
Plasma PK parameters of midazolam and 1-OH midazolam
Cmax and AUC prior to versus following AMG 581 administration
Measured: 36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia or Schizoaffective DisorderStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02504476
- Sponsor's protocol ID
- 20130259
- Acronym
- MAD
- Status last verified
- Mar 2016
- First submitted
- 8 Jul 2015
- Last updated
- 7 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AMG 581 in Healthy Subjects or Subjects With Schizophrenia or Schizoaffective Disorder on Antipsychotic Medication
- ClinicalTrials.gov ID
- NCT02504476
- Acronym / sponsor ID
- MAD / 20130259
- Keywords
- Schizophrenia or Schizoaffective Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 22 Jul 2015 (estimated)
- 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.
The purpose of this study is to find out the time it takes to absorb, distribute, breakdown and remove the drug from the body in healthy participants and subjects with schizophrenia and whether it causes any side effects.
Detailed description
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic profile of ascending multiple oral doses of AMG 581 in healthy subjects or subjects with schizophrenia or schizoaffective disorder on antipsychotic medication. The study will also assess the effects of AMG 581 on midazolam PK in healthy subjects or subjects with schizophrenia or schizoaffective disorder on antipsychotic medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| AMG 581 - Dose 1 | Active comparator | Drug: AMG 581 |
| AMG 581 - Dose 2 | Active comparator | Drug: AMG 581 |
| AMG 581 - Dose 3 | Active comparator | Drug: AMG 581 |
| AMG 581 - Dose 4 | Active comparator | Drug: AMG 581 |
| Placebo - Dose 1 | Placebo comparator | Drug: AMG 581, Drug: Placebo |
| Placebo - Dose 2 | Placebo comparator | Drug: Placebo |
| Placebo - Dose 3 | Placebo comparator | Drug: Placebo |
| Placebo - Dose 4 | Placebo comparator | Drug: Placebo |
| AMG 581/Midazolam - Drug Interaction | Other | Drug: AMG 581, Drug: Midazolam |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Provided informed consent prior to initiation of any study-specific activities/procedures; -male or female subjects should be between the ages of 18 and 45 years (18-55 years for subjects with schizophrenia);-non-nicotine or non-tobacco (healthy subjects only); - no history of relevant medical disorders; - BMI ≥ 18.0; - females of non-reproductive potential; - males practicing effective birth control; - avoid tanning/direct sunlight; - schizophrenia or schizoaffective disorder; PANSS score ≤ 4 points on following items (i.e. conceptual disorganization, hallucinatory behavior, excitement, suspiciousness/persecution, hostility, depression, anxiety, disorientation, uncooperativeness, disturbance of volition, and poor impulse control) / total score ≤ 80 points
Key exclusion criteria (1 listed)
- females lactating/breastfeeding; pregnant partners of male subjects; essential tremor or gait disturbance; - history of hereditary shorten QT syndrome; - malignancy or tumor (other than skin cancers); - history of GI disease that could interfere with absorption; - QTc ≥ 450 msec or ≤ 380 msec; - HbA1c ≥ 7%;
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 |
|---|---|---|
| AMG 581Active drug | Drug | AMG 581 - Dose 1, AMG 581 - Dose 2, AMG 581 - Dose 3, AMG 581 - Dose 4, AMG 581/Midazolam - Drug Interaction, Placebo - Dose 1 |
| PlaceboPlacebo | Drug | Placebo - Dose 1, Placebo - Dose 2, Placebo - Dose 3, Placebo - Dose 4 |
| MidazolamInteraction | Drug | AMG 581/Midazolam - Drug Interaction |
Primary outcome
Reported treatment-emergent adverse events
Time frame: 39 days
Number and percent of subjects experiencing adverse events
Changes in systolic/diastolic blood pressure
Time frame: 39 days
Summaries over time and/or changes from baseline over time in systolic and/or diastolic blood pressure
Changes in heart rate
Time frame: 39 days
Summaries over time and/or changes from baseline over time in heart rate
Changes in respiratory rate
Time frame: 39 days
Summaries over time and/or changes from baseline over time in respiratory rate
Changes in temperature
Time frame: 39 days
Summaries over time and/or changes from baseline over time in temperature
Changes in ECGs
Time frame: 39 days
Summaries over time and/or changes from baseline over time in ECGs
Maximum change from baseline in QTc in ECGs and number and percentage of subjects with maximum changes exceeding prespecified limits in each group
Time frame: 39 days
Subjects' maximum change from baseline in QTc and the number and percentage of subjects in each group
Maximum post-baseline QTc values and number and percentage of subjects with maximum post-baseline QTc values exceeding prespecified limits in each group
Time frame: 39 days
Subjects' maximum post-baseline values and the number and percentage of subjects in each group
Scores at each study visit for Simpson Angus Scale (SAS)
Time frame: 39 days
Summaries over time and/or changes from baseline over time in changes in Simpson Angus Scale (SAS) score
Scores at each study visit for Barnes Akathisia Rating Scale (BARS)
Time frame: 39 days
Summaries over time and/or changes from baseline over time in in Barnes Akathisia Rating Scale (BARS) score
Subject incidence of treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: 39 days
Subject incidence of treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) summarized by cohort
4 secondary outcomes
Compare PK parameter (Cmax) between Day 1 and Day 18
Time frame: 18 days
Compare PK parameter (AUC) between Day 1 and Day 18
Time frame: 18 days
Compare PK parameter (tmax) Compare PK parameter (tmax) between Day 1 and Day 18
Time frame: 18 days
Plasma PK parameters of midazolam and 1-OH midazolam
Time frame: 36 days
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 7 Mar 2016.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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.
MD study director
Amgen
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 AMG 581 and Midazolam in people with Schizophrenia or Schizoaffective Disorder, run by Amgen at 2 sites 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 1 inclusion and 1 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 7 Mar 2016. 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 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?
Reported treatment-emergent adverse events (time frame: 39 days). The study lists 11 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 7 Mar 2016.