SchizophreniaPhase 1NCT02331433
Safety, Tolerability, and Pharmacokinetics of Single Doses of APN1125 in Healthy Normal Subjects
A Phase 1 study testing APN1125 in people with Schizophrenia, run by CoMentis at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of APN1125 when administered as single doses to healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- APN1125
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Dec 2015
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males and females
- Aged 18 to 65 years, inclusive
- Body mass index (BMI) of 18 to 32kg/m^2 inclusive at Screening
- Non-smoker or no tobacco/nicotine usage with 30 days of Screening
Who cannot join
- Personal or family history of neurological, cardiovascular, renal, hepatic, metabolic, gastrointestinal or endocrine abnormalities
- Any clinical abnormality in cardiovascular (e.g., blood pressure) or electrocardiogram (ECG) parameters at Screening and check-in
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of APN1125 in Healthy Normal Subjects
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of APN1125 when administered as single doses to healthy adult subjects.
Read the detailed description
The study will consist of 2 parts: (1) a single dose in healthy adult volunteers, (2) effect of food upon pharmacokinetics of a single dose of APN1125 in healthy adult volunteers.
- Conditions
- Schizophrenia
- Being tested
- APN1125, Placebo
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APN1125Drug
APN1125 orally at ascending doses
PlaceboDrug
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| Experimental: 1 | Experimental | Not described Receives: Drug: APN1125 |
| Placebo Comparator: 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of safety and tolerability of APN1125 in healthy subjects via adverse events
Measured: 8 days
Assessment of safety and tolerability of APN1125 in healthy subjects via vital signs (e.g., blood pressure, pulse rate, respiratory rate, oral temperature)
Measured: 8 days
Assessment of safety and tolerability of APN1125 in healthy subjects via ECGs
Measured: 8 days
Assessment of safety and tolerability of APN1125 in healthy subjects via physical exams
Measured: 8 days
Assessment of safety and tolerability of APN1125 in healthy subjects via clinical laboratory tests (chemistry, hematology, coagulation and urinalysis)
Measured: 8 days
Secondary outcomes (12)
Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: maximum observed plasma concentration (Cmax)
Measured: 24 hours
Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: time corresponding to occurrence of Cmax (tmax)
Measured: 24 hours
Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: Area under the Curve from time zero to the last quantifiable concentration (AUClast)
Measured: 24 hours
Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: Area under the Curve from time zero extrapolated to infinity (AUCinf)
Measured: 24 hours
Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: terminal elimination rate constant (lz)
Measured: 24 hours
Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: apparent elimination half-life (t1/2)
Measured: 24 hours
Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: apparent plasma clearance (CL/F)
Measured: 24 hours
Assessment of pharmacokinetics of APN1125 in urine following single oral doses: apparent volume of distribution (Vz/F)
Measured: 24 hours
Assessment of pharmacokinetics of APN1125 in urine following single oral doses: urinary excretion (Ae)
Measured: 24 hours
Assessment of pharmacokinetics of APN1125 in urine following single oral doses: fraction of APN1125 dose excreted (Fe)
Measured: 24 hours
Assessment of pharmacokinetics of APN1125 in urine following single oral doses: urinary excretion expressed as percentage of dose administered (Ae%)
Measured: 24 hours
Assessment of pharmacokinetics of APN1125 in urine following single oral doses: renal clearance calculated as APN1125 (CLR)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- CoMentis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alpharmagen, Inc.
- Responsible party
- Sponsor
- Investigators
- David Han, MD, Principal investigator, California Clinical Trials Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331433
- Sponsor's protocol ID
- APN1125-001
- Status last verified
- Mar 2016
- First submitted
- 26 Dec 2014
- Last updated
- 8 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of APN1125 in Healthy Normal Subjects
- ClinicalTrials.gov ID
- NCT02331433
- Acronym / sponsor ID
- APN1125-001
- Conditions
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- CoMentisIndustry (pharma, biotech, devices)
- Collaborators
- Alpharmagen, Inc.
- Study start
- Dec 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 6 Jan 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 evaluate the safety, tolerability, and pharmacokinetics of APN1125 when administered as single doses to healthy adult subjects.
Detailed description
The study will consist of 2 parts: (1) a single dose in healthy adult volunteers, (2) effect of food upon pharmacokinetics of a single dose of APN1125 in healthy adult volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: 1 | Experimental | Drug: APN1125 |
| Placebo Comparator: 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy males and females
- Aged 18 to 65 years, inclusive
- Body mass index (BMI) of 18 to 32kg/m^2 inclusive at Screening
- Non-smoker or no tobacco/nicotine usage with 30 days of Screening
Key exclusion criteria (2 listed)
- Personal or family history of neurological, cardiovascular, renal, hepatic, metabolic, gastrointestinal or endocrine abnormalities
- Any clinical abnormality in cardiovascular (e.g., blood pressure) or electrocardiogram (ECG) parameters at Screening and check-in
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 |
|---|---|---|
| APN1125APN1125 orally at ascending doses | Drug | Experimental: 1 |
| PlaceboMatching Placebo | Drug | Placebo Comparator: 2 |
Primary outcome
Assessment of safety and tolerability of APN1125 in healthy subjects via adverse events
Time frame: 8 days
Assessment of safety and tolerability of APN1125 in healthy subjects via vital signs (e.g., blood pressure, pulse rate, respiratory rate, oral temperature)
Time frame: 8 days
Assessment of safety and tolerability of APN1125 in healthy subjects via ECGs
Time frame: 8 days
Assessment of safety and tolerability of APN1125 in healthy subjects via physical exams
Time frame: 8 days
Assessment of safety and tolerability of APN1125 in healthy subjects via clinical laboratory tests (chemistry, hematology, coagulation and urinalysis)
Time frame: 8 days
12 secondary outcomes
Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: maximum observed plasma concentration (Cmax)
Time frame: 24 hours
Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: time corresponding to occurrence of Cmax (tmax)
Time frame: 24 hours
Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: Area under the Curve from time zero to the last quantifiable concentration (AUClast)
Time frame: 24 hours
Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: Area under the Curve from time zero extrapolated to infinity (AUCinf)
Time frame: 24 hours
Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: terminal elimination rate constant (lz)
Time frame: 24 hours
Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: apparent elimination half-life (t1/2)
Time frame: 24 hours
Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: apparent plasma clearance (CL/F)
Time frame: 24 hours
Assessment of pharmacokinetics of APN1125 in urine following single oral doses: apparent volume of distribution (Vz/F)
Time frame: 24 hours
Assessment of pharmacokinetics of APN1125 in urine following single oral doses: urinary excretion (Ae)
Time frame: 24 hours
Assessment of pharmacokinetics of APN1125 in urine following single oral doses: fraction of APN1125 dose excreted (Fe)
Time frame: 24 hours
Assessment of pharmacokinetics of APN1125 in urine following single oral doses: urinary excretion expressed as percentage of dose administered (Ae%)
Time frame: 24 hours
Assessment of pharmacokinetics of APN1125 in urine following single oral doses: renal clearance calculated as APN1125 (CLR)
Time frame: 24 hours
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 8 Apr 2016.
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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.
David Han, MD principal investigator
California Clinical Trials Medical Group
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 APN1125 in people with Schizophrenia, run by CoMentis 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 2 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 8 Apr 2016. 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?
Assessment of safety and tolerability of APN1125 in healthy subjects via adverse events (time frame: 8 days). The study lists 5 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 8 Apr 2016.