Healthy Japanese Young and Elderly Male and Non-fertile Female VolunteersPhase 1NCT02005211

A Two-part Single and Multiple Dose Study to Assess the Safety , Pharmacokinetics and Effects of AZD3293 in Healthy Japanese Young and Elderly Volunteers

A Phase 1 study testing AZD3293 in people with Healthy Japanese Young and Elderly Male and Non-fertile Female Volunteers, run by AstraZeneca at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study consists of two parts, ie, single dose part with young healthy subjects (Part 1) and single and multiple dose part with elderly healthy subjects (Part 2), to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD3293 following single and multiple ascending dose administration to… Read more about this study

Who is it for?: Ages 20 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Japanese Young and Elderly Male and Non-fertile Female Volunteers
What is being tested?: AZD3293
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 114 participants
Where: 1 siteJapan
Study dates: Dec 2013to Jul 2014
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy Japanese elderly and young males and females (of non-childbearing potential)
Body mass index (BMI) between 17 and 27 kg/m2 and weigh at least 40 kg and no more than 100 kg

Who cannot join

Psychiatric disease/condition, GI, renal, hepatic, cardiovascular, psychiatric, or retinal diseases or disorders
Use of antipsychotic drugs , or chronic use of antidepressant or anxiolytic drugs.
Frequent use (more than 2 days per week during the last 12 weeks) of tobacco or other nicotine products.
Neurological disease, including seizures, recent memory impairment, or clinically significant head injury.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Research Site
Fukuoka

Other trials in Japan

About this study

Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Effect on Biomarkers of AZD3293 in Healthy Japanese Male and Non-Fertile Female Volunteers Including Elderly

Read the detailed description

This is a Phase I, randomised, double-blind, placebo-controlled, single centre study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD3293 following single and multiple ascending dose administration to healthy subjects. This study consists of two parts, ie, single dose part with young healthy subjects (Part 1) and single and multiple dose part with elderly healthy subjects (Part 2). The study design allows a gradual escalation of dosage levels between sequential cohorts with safety monitoring to ensure the safety of the healthy subjects.

Conditions: Healthy Japanese Young and Elderly Male and Non-fertile Female Volunteers
Being tested: AZD3293, Placebo
Keywords: AZD3293, Healthy volunteers, Young volunteers, Elderly volunteers, Japanese volunteers, Phase 1, Single and multiple ascending dose study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD3293Drug
Oral solution
PlaceboDrug
Oral solution

Study groups in NCT02005211
Study group	Role	What they receive
AZD3293	Experimental	AZD3293 will be administered as single dose of an oral solution in Part 1 and single and multiple doses of an oral solution in Part 2. The ascending doses are planned to be 15, 50 and 150 mg for young subjects in Part 1 and 15 and 50 mg for elderly subjects in Part 2. Before proceeding to next dose level, safety, tolerability and pharmacokinetic data from the previous cohort(s) will be evaluated by a Safety Review Committee. Part 2 will start after confirming safety and tolerability in Part 1. Receives: Drug: AZD3293
Placebo	Placebo comparator	Placebo given (2 subjects in each cohort) Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety - Adverse Events
Safety - Number of subjects reporting any adverse events during the study
Measured: Day of first dose to follow up

Secondary outcomes (3)

PK Cmax - Overall Study
Pharmacokinetic maximum concentration
Measured: 0, 0.5,1,2,3,4,8,12,24,48 hr single dose, multiple dose does not include 48 hr
PK AUC - Overall Study (SAD & MAD Parts)
Pharmacokintic Area Under the Curve (0 to t)
Measured: 0,0.5,1,2,3,4,8,12,24,48 hr single dose, multiple dose does not include 48 hr
Biomarker
Biomarker (Abeta 1-40; A beta 1-42) % change from baseline
Measured: Pre dose vs Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2013Jul 2014

First posted9 Dec 2013 (estimated)
Study startDec 2013
Primary completionJul 2014
Study completionJul 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy Japanese Young and Elderly Male and Non-fertile Female 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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 114 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02005211
Sponsor's protocol ID: D5010C00003
Status last verified: Sep 2016
First submitted: 4 Dec 2013
Last updated: 4 Nov 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Effect on Biomarkers of AZD3293 in Healthy Japanese Male and Non-Fertile Female Volunteers Including Elderly
ClinicalTrials.gov ID: NCT02005211
Acronym / sponsor ID: D5010C00003
Conditions: Healthy Japanese Young and Elderly Male and Non-fertile Female Volunteers
Keywords: AZD3293, Healthy volunteers, Young volunteers, Elderly volunteers, Japanese volunteers, Phase 1, Single and multiple ascending dose study
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 114 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Dec 2013
Primary completion: Jul 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 9 Dec 2013 (estimated)
Results: Posted 10 Nov 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
AZD3293	Experimental	Drug: AZD3293AZD3293 will be administered as single dose of an oral solution in Part 1 and single and multiple doses of an oral solution in Part 2. The ascending doses are planned to be 15, 50 and 150 mg for young subjects in Part 1 and 15 and 50 mg for elderly subjects in Part 2. Before proceeding to next dose level, safety, tolerability and pharmacokinetic data from the previous cohort(s) will be evaluated by a Safety Review Committee. Part 2 will start after confirming safety and tolerability in Part 1.
Placebo	Placebo comparator	Drug: PlaceboPlacebo given (2 subjects in each cohort)

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Healthy Japanese elderly and young males and females (of non-childbearing potential)
Body mass index (BMI) between 17 and 27 kg/m2 and weigh at least 40 kg and no more than 100 kg

Key exclusion criteria (4 listed)

Psychiatric disease/condition, GI, renal, hepatic, cardiovascular, psychiatric, or retinal diseases or disorders
Use of antipsychotic drugs , or chronic use of antidepressant or anxiolytic drugs.
Frequent use (more than 2 days per week during the last 12 weeks) of tobacco or other nicotine products.
Neurological disease, including seizures, recent memory impairment, or clinically significant head injury.

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
AZD3293Oral solution	Drug	AZD3293
PlaceboOral solution	Drug	Placebo

Primary outcome

Safety - Adverse Events
Time frame: Day of first dose to follow up
Safety - Number of subjects reporting any adverse events during the study

3 secondary outcomes

PK Cmax - Overall Study
Time frame: 0, 0.5,1,2,3,4,8,12,24,48 hr single dose, multiple dose does not include 48 hr
PK AUC - Overall Study (SAD & MAD Parts)
Time frame: 0,0.5,1,2,3,4,8,12,24,48 hr single dose, multiple dose does not include 48 hr
Biomarker
Time frame: Pre dose vs Day 14

Results and safety

Results posted to the registry on 10 Nov 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Part 1	6	6
AZD3293 15 mg Part 1	6	6
AZD3293 50 mg Part 1	6	6
AZD3293 150 mg Part 1	6	6
AZD3293 15 mg Part 2	0	0
AZD3293 50 mg Part 2	0	0
Placebo Part 2	0	0

Primary outcome: Safety - Adverse Events

Time frame: Day of first dose to follow up. Number. Unit: Participants

Measure	AZD3293 15 mg Part 1 n = 6	AZD3293 50 mg Part 1 n = 6	AZD3293 150 mg Part 1 n = 6	AZD3293 15 mg Part 2 n = 6	AZD3293 50 mg Part 2 n = 6	Placebo Part 1 n = 6	Placebo Part2 n = 4
Value	1	1	0	2	2	1	1

Population analysed: Safety

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 10 days after last dose, for Part 1: 7 to 10 days; for Part 2: 21 to 24 days. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Part 1	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
AZD3293 15 mg Part 1	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
AZD3293 50 mg Part 1	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
AZD3293 150 mg Part 1	0 of 6 (0%)	0 of 6 (0%)	Not reported
AZD3293 15 mg Part 2	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
AZD3293 50 mg Part 2	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
Placebo Part 2	0 of 4 (0%)	1 of 4 (25%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

Robert C Alexander, MD study director

AstraZeneca

Kei Sakamoto, MD, PhD principal investigator

Sugioka Memorial Hospital, Medical Co. LTA

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 AZD3293 in people with Healthy Japanese Young and Elderly Male and Non-fertile Female Volunteers, run by AstraZeneca at 1 site in Japan.

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 2 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: finished, as of the sponsor's last update on 4 Nov 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 Japan. 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?

Yes. Results are posted in the registry (first posted 10 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 - Adverse Events (time frame: Day of first dose to follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02005211.

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 Nov 2016.