Healthy Volunteers.Phase 1AZD6423NCT01926366
AZD6423 SAD/MAD Study in Healthy Volunteers
A Phase 1 study testing AZD6423 in people with Healthy Volunteers., run by AstraZeneca at 1 site in United States.
Trial summary
This is a randomized, double-blind, placebo-controlled study of single and multiple ascending dosage levels of AZD6423 in healthy volunteers. The study includes an up to 28-day screening period, an in-house period during which AZD6423 or placebo will be administered IV, and a 4- to 10-day follow-up period after… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers.
- What is being tested?
- AZD6423
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Mar 2014
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Subjects must understand the nature of the study and must provide signed and dated written informed consent in accordance with local regulations before the conduct of any study-specific procedures.
- All male subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control for the duration of the study and for 15 days after dose administration. A male subject is considered biologically capable of having children even if his sexual partner is sterile or using contraceptives.
- Subjects must have a body mass index (BMI) between 19 and 30, inclusive and weigh between 50kg and 100kg inclusive.
- Subjects must be fluent in English.
Who cannot join
- A history or presence of a clinically significant hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, or neurologic abnormality.
- A clinically significant abnormality on physical examination, neurological examination, EEG, ECG, vital signs or laboratory evaluations at screen or between screen and dose administration.
- A history of seizure.
- A history of head trauma, including closed head injury with loss of consciousness.
- Any history of suicide attempt or suicidal behavior, or, in the opinion of the investigator, clinically significant risk of suicide or violent behavior.
- Urine drug screen positive for a drug of abuse
- A family history of schizophrenia, schizoaffective disorder, or psychosis in first degree relatives.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Third-Party-Unblinded, Placebo-Controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of AZD6423 in Healthy Volunteers
This is a randomized, double-blind, placebo-controlled study of single and multiple ascending dosage levels of AZD6423 in healthy volunteers. The study includes an up to 28-day screening period, an in-house period during which AZD6423 or placebo will be administered IV, and a 4- to 10-day follow-up period after discharge.
Read the detailed description
In Part 1 of the study (single ascending dose portion), approximately 40 subjects will be randomly assigned. Eight (8) subjects will be randomized in each of 5 dosage-level cohorts (AZD6423 or placebo). Within each cohort, 6 subjects will be randomized to receive AZD6423 and 2 subjects will be randomized to receive placebo. Each subject will receive only one dose of either AZD6423 or placebo on Day 1. In Part 2 of the study (multiple ascending dose portion), approximately 24 subjects will be randomly assigned. Eight (8) subjects will be randomized in each of 3 dosage-level cohorts. Within each cohort, 6 subjects will be randomized to receive AZD6423 and 2 subjects will be randomized to receive placebo. Each subject will receive three doses of either AZD6423 or placebo.
- Conditions
- Healthy Volunteers.
- Being tested
- AZD6423, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD6423Drug
Drug: AZD6423 Single or Multiple doses via infusion.
PlaceboDrug
Placebo to match AZD6423 Single or Multiple doses of matching placebo delivered via infusion
| Study group | Role | What they receive |
|---|---|---|
| Experimental: AZD6423 | Experimental | Subjects will participate in 1 of 8 groups and receive single or multiple doses of AZD6423 or matching placebo. In each group 6 subjects will receive AZD6423 and 2 subjects will receive matching placebo. Receives: Drug: AZD6423 |
| Placebo to match AZD6423 | Placebo comparator | Subjects will participate in 1 of 8 groups and receive single or multiple doses of AZD6423 or matching placebo. In each group 6 subjects will receive AZD6423 and 2 subjects will receive matching placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the safety and tolerability of AZD6423 in healthy subjects via adverse events
The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers.
Measured: From Baseline up to 18 days
Assessment of the safety and tolerability of AZD6423 in healthy subjects via EEG
The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers.
Measured: From Baseline up to 6 days
Assessment of the safety and tolerability of AZD6423 in healthy subjects via ECG.
The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers.
Measured: From Baseline up to 18 days
Assessment of the safety and tolerability of AZD6423 in healthy subjects via vital signs (blood pressure and pulse). as well as body temperature and weight
The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers.
Measured: From Baseline up to 18 days
Assessment of the safety and tolerability of AZD6423 in healthy subjects via clinical laboratory tests (chemistry, hematology and urinalysis).
The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers.
Measured: From Baseline up to 18 days
Assessment of the safety and tolerability of AZD6423 in healthy subjects via psychiatric assessments.
The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers.
Measured: From Baseline up to 18 days
Assessment of the safety and tolerability of AZD6423 in healthy subjects via neurological exams.
The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers.
Measured: From Baseline up to 18 days
Assessment of the safety and tolerability of AZD6423 in healthy subjects via physical exams.
The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers.
Measured: From Baseline up to 18 days
Secondary outcomes (2)
Description of the PK profile for AZD6423 in terms of: observed maximum plasma concentration (Cmax), time to reach maximum plasma concentration (tmax), terminal rate constant (λz), terminal half-life (t½ z), and area under the curve (AUC).
Secondary objectives are to assess the pharmacokinetics and pharmacodynamics of AZD6423 in healthy volunteers.
Measured: From Baseline up to 7 days
Assessment of the pharmacodynamics of AZD6423 in terms of the relationship between plasma concentration of AZD6423 and EEG
Secondary objectives are to assess the pharmacokinetics and pharmacodynamics of AZD6423 in healthy volunteers.
Measured: From Baseline up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers.Studies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Han, M.D., Principal investigator, California Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926366
- Sponsor's protocol ID
- D3521C00001
- Acronym
- AZD6423
- Status last verified
- Apr 2014
- First submitted
- 12 Aug 2013
- Last updated
- 4 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Third-Party-Unblinded, Placebo-Controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of AZD6423 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01926366
- Acronym / sponsor ID
- AZD6423 / D3521C00001
- Conditions
- Healthy Volunteers.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 20 Aug 2013 (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 randomized, double-blind, placebo-controlled study of single and multiple ascending dosage levels of AZD6423 in healthy volunteers. The study includes an up to 28-day screening period, an in-house period during which AZD6423 or placebo will be administered IV, and a 4- to 10-day follow-up period after discharge.
Detailed description
In Part 1 of the study (single ascending dose portion), approximately 40 subjects will be randomly assigned. Eight (8) subjects will be randomized in each of 5 dosage-level cohorts (AZD6423 or placebo). Within each cohort, 6 subjects will be randomized to receive AZD6423 and 2 subjects will be randomized to receive placebo. Each subject will receive only one dose of either AZD6423 or placebo on Day 1. In Part 2 of the study (multiple ascending dose portion), approximately 24 subjects will be randomly assigned. Eight (8) subjects will be randomized in each of 3 dosage-level cohorts. Within each cohort, 6 subjects will be randomized to receive AZD6423 and 2 subjects will be randomized to receive placebo. Each subject will receive three doses of either AZD6423 or placebo.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: AZD6423 | Experimental | Drug: AZD6423Subjects will participate in 1 of 8 groups and receive single or multiple doses of AZD6423 or matching placebo. In each group 6 subjects will receive AZD6423 and 2 subjects will receive matching placebo. |
| Placebo to match AZD6423 | Placebo comparator | Drug: PlaceboSubjects will participate in 1 of 8 groups and receive single or multiple doses of AZD6423 or matching placebo. In each group 6 subjects will receive AZD6423 and 2 subjects will receive matching placebo. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must understand the nature of the study and must provide signed and dated written informed consent in accordance with local regulations before the conduct of any study-specific procedures.
- All male subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control for the duration of the study and for 15 days after dose administration. A male subject is considered biologically capable of having children even if his sexual partner is sterile or using contraceptives.
- Subjects must have a body mass index (BMI) between 19 and 30, inclusive and weigh between 50kg and 100kg inclusive.
- Subjects must be fluent in English.
Key exclusion criteria (7 listed)
- A history or presence of a clinically significant hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, or neurologic abnormality.
- A clinically significant abnormality on physical examination, neurological examination, EEG, ECG, vital signs or laboratory evaluations at screen or between screen and dose administration.
- A history of seizure.
- A history of head trauma, including closed head injury with loss of consciousness.
- Any history of suicide attempt or suicidal behavior, or, in the opinion of the investigator, clinically significant risk of suicide or violent behavior.
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 |
|---|---|---|
| AZD6423Drug: AZD6423 Single or Multiple doses via infusion. | Drug | Experimental: AZD6423 |
| PlaceboPlacebo to match AZD6423 Single or Multiple doses of matching placebo delivered via infusion | Drug | Placebo to match AZD6423 |
Primary outcome
Assessment of the safety and tolerability of AZD6423 in healthy subjects via adverse events
Time frame: From Baseline up to 18 days
The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers.
Assessment of the safety and tolerability of AZD6423 in healthy subjects via EEG
Time frame: From Baseline up to 6 days
The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers.
Assessment of the safety and tolerability of AZD6423 in healthy subjects via ECG.
Time frame: From Baseline up to 18 days
The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers.
Assessment of the safety and tolerability of AZD6423 in healthy subjects via vital signs (blood pressure and pulse). as well as body temperature and weight
Time frame: From Baseline up to 18 days
The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers.
Assessment of the safety and tolerability of AZD6423 in healthy subjects via clinical laboratory tests (chemistry, hematology and urinalysis).
Time frame: From Baseline up to 18 days
The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers.
Assessment of the safety and tolerability of AZD6423 in healthy subjects via psychiatric assessments.
Time frame: From Baseline up to 18 days
The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers.
Assessment of the safety and tolerability of AZD6423 in healthy subjects via neurological exams.
Time frame: From Baseline up to 18 days
The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers.
Assessment of the safety and tolerability of AZD6423 in healthy subjects via physical exams.
Time frame: From Baseline up to 18 days
The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers.
2 secondary outcomes
Description of the PK profile for AZD6423 in terms of: observed maximum plasma concentration (Cmax), time to reach maximum plasma concentration (tmax), terminal rate constant (λz), terminal half-life (t½ z), and area under the curve (AUC).
Time frame: From Baseline up to 7 days
Assessment of the pharmacodynamics of AZD6423 in terms of the relationship between plasma concentration of AZD6423 and EEG
Time frame: From Baseline up to 7 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 4 Apr 2014.
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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, M.D. principal investigator
California Clinical Trials
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 AZD6423 in people with Healthy Volunteers., 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 4 inclusion and 7 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 4 Apr 2014. 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 the safety and tolerability of AZD6423 in healthy subjects via adverse events (time frame: From Baseline up to 18 days). The study lists 8 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 4 Apr 2014.