Bipolar DisorderPhase 1AZD4451 SADNCT01196676
Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4451
A Phase 1 study testing AZD4451 in people with Bipolar Disorder, run by AstraZeneca at 1 site in United States.
Trial summary
This is a single ascending dose study to assess the safety, tolerability and pharmacokinetics of AZD4451. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- AZD4451
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Apr 2011
- 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
- Provide a signed and dated, written informed consent prior to any study specific procedures being performed. including the genetic sampling and analyses. If a volunteer declines to participate in the genetic component of the study, there will be no penalty or loss of benefit to the volunteer. The volunteer will not be excluded from other aspects of the study described in this protocol.
- Healthy male and female (of non-childbearing potential) volunteers 18 to 55 years old inclusive with suitable veins for cannulation or repeated venipuncture.
- Females must have a negative pregnancy test at screening and on admission to the unit, must not be nursing and must be of non-childbearing potential, confirmed at screening by fulfilling one of the following criteria:
- Post-menopausal defined as amenorrhoea for at least 12 months following cessation of all exogenous hormonal treatments and with FSH levels in the laboratory defined post-menopausal range
- Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation Male volunteers should be willing to use barrier contraception for example, condoms and spermicide, from the day of dosing until at least 3 months after dosing with the investigational product.
- Have a body mass index (BMI) between 19 and 30 kg/m2 (BMI <30.5 =30) and weigh at least 50 kg and no more than 100 kg inclusive.
Who cannot join
- History of gastrointestinal surgery (other than cholecystectomy or appendectomy) or unintentional rapid weight loss.
- A positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus (HIV).
- History of any of the following as judged by the Investigator: History of psychiatric disorders as defined in the Diagnostic and Statistical Manual of Mental Disorders text revision; Medically diagnosed depression in the 6 months prior to dosing; Bipolar disorder; Use of psychoactive medication (including mood stabilizers) in the 6 months prior to dosing; Electroconvulsive therapy in the 6 months prior to dosing; History of seizures 1 year prior to dosing; History of severe dystonic reaction to other drugs.
- History of syncope, fainting or of vasovagal reactions; history of arrhythmias, and/or postural hypotension. The inclusion of volunteers meeting the above criteria may be decided on a case-by-case basis after consultation between the Investigator and AZ CPA physician.
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Double- Blind, Placebo- Controlled, Single-center Study, to Assess the Safety, Tolerability and Pharmacokinetics of AZD4451 Following Single Ascending Oral Dose Administration in Healthy Subjects
This is a single ascending dose study to assess the safety, tolerability and pharmacokinetics of AZD4451.
- Conditions
- Bipolar Disorder
- Being tested
- AZD4451, Placebo
- Keywords
- AZD4451, Bipolar, depression
- Medical subject headings
- Bipolar Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD4451Drug
1 mg capsules, 5 mg capsules, and 25 mg capsules
PlaceboDrug
1 mg capsules, 5 mg capsules, and 25 mg capsules
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AZD4451 Receives: Drug: AZD4451 |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of single ascending oral doses of AZD4451 by assessing AEs, vital signs, physical examinations, neurological examinations clinical laboratory parameters, Columbia Suicide Severity Rating Scale(CSSRS), EEGs and ECGs
Measured: Screening to end of study.
Secondary outcomes (2)
To assess the pharmacokinetics of single ascending oral doses of AZD4451 by maximum plasma concentration (Cmax).
Measured: Predose, 30 min, 1 hr, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 18, 24, 30, 48, and 72 hours postdose.
To evaluate and characterize the PK of AZD4451 and its metabolites AZ13263197 and AZ13263195 when given orally in single ascending doses by assessment of drug concentration in urine.
Measured: Urine will be collectioned for 72 hours post-dose. Pre-dose to 12 hours, 12-24, 24- 48 and 48-72 hours post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mark Smith, Study director, AstraZeneca, LP, 1800 Concord Pike, Wilmington, DERalph Schutz, Principal investigator, Quintiles Phase I Services, 6700 West 115th Street, Overland Park, Kansas 66211
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196676
- Sponsor's protocol ID
- D3600C00001
- Acronym
- AZD4451 SAD
- Status last verified
- Jul 2011
- First submitted
- 20 Aug 2010
- Last updated
- 1 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double- Blind, Placebo- Controlled, Single-center Study, to Assess the Safety, Tolerability and Pharmacokinetics of AZD4451 Following Single Ascending Oral Dose Administration in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01196676
- Acronym / sponsor ID
- AZD4451 SAD / D3600C00001
- Conditions
- Bipolar Disorder
- Keywords
- AZD4451, Bipolar, depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 8 Sep 2010 (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.
This is a single ascending dose study to assess the safety, tolerability and pharmacokinetics of AZD4451.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD4451AZD4451 |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Provide a signed and dated, written informed consent prior to any study specific procedures being performed. including the genetic sampling and analyses. If a volunteer declines to participate in the genetic component of the study, there will be no penalty or loss of benefit to the volunteer. The volunteer will not be excluded from other aspects of the study described in this protocol.
- Healthy male and female (of non-childbearing potential) volunteers 18 to 55 years old inclusive with suitable veins for cannulation or repeated venipuncture.
- Females must have a negative pregnancy test at screening and on admission to the unit, must not be nursing and must be of non-childbearing potential, confirmed at screening by fulfilling one of the following criteria:
- Post-menopausal defined as amenorrhoea for at least 12 months following cessation of all exogenous hormonal treatments and with FSH levels in the laboratory defined post-menopausal range
- Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation Male volunteers should be willing to use barrier contraception for example, condoms and spermicide, from the day of dosing until at least 3 months after dosing with the investigational product.
Key exclusion criteria (5 listed)
- History of gastrointestinal surgery (other than cholecystectomy or appendectomy) or unintentional rapid weight loss.
- A positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus (HIV).
- History of any of the following as judged by the Investigator: History of psychiatric disorders as defined in the Diagnostic and Statistical Manual of Mental Disorders text revision; Medically diagnosed depression in the 6 months prior to dosing; Bipolar disorder; Use of psychoactive medication (including mood stabilizers) in the 6 months prior to dosing; Electroconvulsive therapy in the 6 months prior to dosing; History of seizures 1 year prior to dosing; History of severe dystonic reaction to other drugs.
- History of syncope, fainting or of vasovagal reactions; history of arrhythmias, and/or postural hypotension. The inclusion of volunteers meeting the above criteria may be decided on a case-by-case basis after consultation between the Investigator and AZ CPA physician.
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
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 |
|---|---|---|
| AZD44511 mg capsules, 5 mg capsules, and 25 mg capsules | Drug | 1 |
| Placebo1 mg capsules, 5 mg capsules, and 25 mg capsules | Drug | 2 |
Primary outcome
To assess the safety and tolerability of single ascending oral doses of AZD4451 by assessing AEs, vital signs, physical examinations, neurological examinations clinical laboratory parameters, Columbia Suicide Severity Rating Scale(CSSRS), EEGs and ECGs
Time frame: Screening to end of study.
2 secondary outcomes
To assess the pharmacokinetics of single ascending oral doses of AZD4451 by maximum plasma concentration (Cmax).
Time frame: Predose, 30 min, 1 hr, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 18, 24, 30, 48, and 72 hours postdose.
To evaluate and characterize the PK of AZD4451 and its metabolites AZ13263197 and AZ13263195 when given orally in single ascending doses by assessment of drug concentration in urine.
Time frame: Urine will be collectioned for 72 hours post-dose. Pre-dose to 12 hours, 12-24, 24- 48 and 48-72 hours post-dose.
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 1 Aug 2011.
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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.
Mark Smith study director
AstraZeneca, LP, 1800 Concord Pike, Wilmington, DE
Ralph Schutz principal investigator
Quintiles Phase I Services, 6700 West 115th Street, Overland Park, Kansas 66211
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 AZD4451 in people with Bipolar Disorder, run by AstraZeneca 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 6 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: finished, as of the sponsor's last update on 1 Aug 2011. 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?
To assess the safety and tolerability of single ascending oral doses of AZD4451 by assessing AEs, vital signs, physical examinations, neurological examinations clinical laboratory parameters, Columbia Suicide Severity Rating Scale(CSSRS), EEGs and ECGs (time frame: Screening to end of study.). 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 1 Aug 2011.