Healthy VolunteersPhase 1NCT00736788
Assess Safety, Tolerability and Pharmacokinetic (PK) of AZD1704 in Healthy Japanese Male and Non-Fertile Female Volunteers
A Phase 1 study testing AZD1704 in people with Healthy Volunteers, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
The primary objective of this study is to investigate the safety and tolerability of AZD1704 following single ascending doses in healthy Japanese male and non-fertile female volunteers by assessment of adverse events (AEs), vital signs (supine and standing blood pressure, pulse rate, respiratory rate and body… Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- AZD1704
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2008to Sep 2008
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Japanese males and non-fertile females, defined as first generation Japanese (both parents and grandparents are of Japanese origin, the subject is born in Japan and has not been living outside of Japan for more than 5 years) aged 20-45 years .
- Clinical normal physical findings
- BMI 19 - 27, weight 50 - 95 kg
Who cannot join
- History of somatic disease/condition or ongoing psychiatric disease/condition that may interfere with the objectives of the study.
- History of psychotic disorder among first-degree relatives.
- History of use of antipsychotic, antidepressant or anxiolytic drugs, prescribed as well as non-prescribed use.
- Smoking more than 7 cigarettes per week or consumption of more than 3 portion of snuff or equivalent per day within 30 days before administration of study drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single-Centre, Randomised, Double-Blind (Within Panels), Placebo-Controlled Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD1704 After Administration of Oral Single Ascending Doses in Healthy Japanese Male and Non-Fertile Female Volunteers
The primary objective of this study is to investigate the safety and tolerability of AZD1704 following single ascending doses in healthy Japanese male and non-fertile female volunteers by assessment of adverse events (AEs), vital signs (supine and standing blood pressure, pulse rate, respiratory rate and body temperature), safety laboratory variables and 12 lead electrocardiography (ECG). The secondary objectives of the study are: to investigate the subjective CNS effects of orally administered AZD1704 in healthy Japanese male and non-fertile female volunteers on a psychometric rating scale by assessment of specific adjectives (stimulated, anxious, sedated, down and high) rated on visual analogue mood scale (VAMS) and to investigate the pharmacokinetic profile of AZD1704 following single ascending doses in healthy Japanese male and non-fertile female volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- AZD1704, Placebo
- Keywords
- AZD1704,, Japanese, Healthy, Volunteers,, Phase I study,, Single Ascending Dose, Safety,, Tolerability, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1704Drug
single dose oral suspension, 4 different dose levels
PlaceboDrug
single dose oral suspension
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Four different oral dose levels of a suspension containing AZD1704 Receives: Drug: AZD1704 |
| 2 | Placebo comparator | oral suspension Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety/Tolerability - adverse events (AEs), vital signs (supine and standing blood pressure, pulse rate, respiratory rate and body temperature), safety laboratory variables and 12 lead electrocardiography (ECG)
Measured: From dosing to follow up
Secondary outcomes (2)
Pharmacodynamic VAMS scores of different adjectives (stimulated, anxious, sedated, down and high).
Measured: During residential period
Pharmacokinetic profile of AZD1704 following single ascending doses in healthy Japanese male and non-fertile female volunteers
Measured: During residential period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionSep 2008
- Study completionSep 2008
Why it stopped: AZD1704 has essentially similar PK profile in Japanese subjects as in Caucasians. One of the main purposes of the study has thereby been achieved.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Rolf Karlsten, Study director, AstraZeneca R&D SödertäljeUlrike Lorch, Principal investigator, Richmond Pharmacology Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00736788
- Sponsor's protocol ID
- D0980C00005
- Other IDs
- 2008-002153-20, 2008
- Status last verified
- Dec 2010
- First submitted
- 14 Aug 2008
- Last updated
- 10 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Centre, Randomised, Double-Blind (Within Panels), Placebo-Controlled Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD1704 After Administration of Oral Single Ascending Doses in Healthy Japanese Male and Non-Fertile Female Volunteers
- ClinicalTrials.gov ID
- NCT00736788
- Acronym / sponsor ID
- D0980C00005
- Conditions
- Healthy Volunteers
- Keywords
- AZD1704,, Japanese, Healthy, Volunteers,, Phase I study,, Single Ascending Dose, Safety,, Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: AZD1704 has essentially similar PK profile in Japanese subjects as in Caucasians. One of the main purposes of the study has thereby been achieved.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 18 Aug 2008 (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 primary objective of this study is to investigate the safety and tolerability of AZD1704 following single ascending doses in healthy Japanese male and non-fertile female volunteers by assessment of adverse events (AEs), vital signs (supine and standing blood pressure, pulse rate, respiratory rate and body temperature), safety laboratory variables and 12 lead electrocardiography (ECG). The secondary objectives of the study are: to investigate the subjective CNS effects of orally administered AZD1704 in healthy Japanese male and non-fertile female volunteers on a psychometric rating scale by assessment of specific adjectives (stimulated, anxious, sedated, down and high) rated on visual analogue mood scale (VAMS) and to investigate the pharmacokinetic profile of AZD1704 following single ascending doses in healthy Japanese male and non-fertile female volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD1704Four different oral dose levels of a suspension containing AZD1704 |
| 2 | Placebo comparator | Drug: Placebooral suspension |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy Japanese males and non-fertile females, defined as first generation Japanese (both parents and grandparents are of Japanese origin, the subject is born in Japan and has not been living outside of Japan for more than 5 years) aged 20-45 years .
- Clinical normal physical findings
- BMI 19 - 27, weight 50 - 95 kg
Key exclusion criteria (4 listed)
- History of somatic disease/condition or ongoing psychiatric disease/condition that may interfere with the objectives of the study.
- History of psychotic disorder among first-degree relatives.
- History of use of antipsychotic, antidepressant or anxiolytic drugs, prescribed as well as non-prescribed use.
- Smoking more than 7 cigarettes per week or consumption of more than 3 portion of snuff or equivalent per day within 30 days before administration of study drug.
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 |
|---|---|---|
| AZD1704single dose oral suspension, 4 different dose levels | Drug | 1 |
| Placebosingle dose oral suspension | Drug | 2 |
Primary outcome
Safety/Tolerability - adverse events (AEs), vital signs (supine and standing blood pressure, pulse rate, respiratory rate and body temperature), safety laboratory variables and 12 lead electrocardiography (ECG)
Time frame: From dosing to follow up
2 secondary outcomes
Pharmacodynamic VAMS scores of different adjectives (stimulated, anxious, sedated, down and high).
Time frame: During residential period
Pharmacokinetic profile of AZD1704 following single ascending doses in healthy Japanese male and non-fertile female volunteers
Time frame: During residential period
Results and safety
The study was stopped early (reason given: AZD1704 has essentially similar PK profile in Japanese subjects as in Caucasians. One of the main purposes of the study has thereby been achieved.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2010.
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Screening Protocol
Pain
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.
Rolf Karlsten study director
AstraZeneca R&D Södertälje
Ulrike Lorch principal investigator
Richmond Pharmacology Limited
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 AZD1704 in people with Healthy Volunteers, run by AstraZeneca at 1 site in United Kingdom.
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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 10 Dec 2010. 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 Kingdom. 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 was stopped early (reason given: AZD1704 has essentially similar PK profile in Japanese subjects as in Caucasians. One of the main purposes of the study has thereby been achieved.). Results are not available in the source record.
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?
Safety/Tolerability - adverse events (AEs), vital signs (supine and standing blood pressure, pulse rate, respiratory rate and body temperature), safety laboratory variables and 12 lead electrocardiography (ECG) (time frame: From dosing to follow up). 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 10 Dec 2010.