HealthyPhase 1NCT01092299
A Bioavailability Study Comparing Modified-release Capsules and Immediate Release Capsules in Fed and Fasting Conditions
A Phase 1 study testing AZD1446 in people with Healthy, run by AstraZeneca at 2 sites in Sweden.
Trial summary
Part 1: The purpose of this study is to determine the pharmacokinetic profile of 4 different Extended/modified-release formulations and one immediate release formulation of AZD1446. In addition the food effect on AZD1446 pharmacokinetics will be investigated. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AZD1446
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 2 sitesSweden
- Study dates
- Feb 2010to Jul 2010
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) between 19 and 30 kg/m2
- Clinically normal findings on physical examination
Who cannot join
- History of any clinically significant disease or disorder
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- History or present symptoms or signs of severe allergy/hypersensitivity reactions including severe food allergy, as judged by the investigator
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Phase I Study to Investigate the Relative Bioavailability of Modified-release Formulations of AZD1446 Compared to an Immediate-release Capsule Under Fed and Fasting Conditions Following Single and Repeated Dose Administration to Young and Elderly Healthy Volunteers
Part 1: The purpose of this study is to determine the pharmacokinetic profile of 4 different Extended/modified-release formulations and one immediate release formulation of AZD1446. In addition the food effect on AZD1446 pharmacokinetics will be investigated.
Part 2: To asses the safety and tolerability of the selected formulation(s) from part 1 in elderly healthy volunteers.
- Conditions
- Healthy
- Being tested
- AZD1446, Placebo
- Keywords
- Phase I, Relative bioavailability, Pharmacokinetic study, AZD1446, healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1446Drug
ER Fast, 90mg, p.o. capsule
AZD1446Drug
ER Moderate, 90mg, p.o. capsule
AZD1446Drug
ER Slow, 90mg, p.o. capsule
AZD1446Drug
MR
AZD1446Drug
IR, 90 mg p.o. capsule
PlaceboDrug
IR
PlaceboDrug
ER/MR
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (2 arms) | Experimental | Period 1: randomized to either fasting IR or ER1. Period 2: Cross-over to either IR or ER1. Period 3: ER1 in fed conditions. Receives: Drug: AZD1446 |
| Cohort 2 (2 arms) | Experimental | Period 1: randomized to either fasting IR or ER2. Period 2: Cross-over to either IR or ER2. Period 3: ER2 in fed conditions. Receives: Drug: AZD1446 |
| Cohort 3( 2 arms) | Experimental | Period 1: randomized to either fasting IR or ER3. Period 2: Cross-over to either IR or ER3. Period 3: ER3 in fed conditions. Receives: Drug: AZD1446 |
| Cohort 4 (2 arms) | Experimental | Period 1: randomized to either fasting IR or MR4. Period 2: Cross-over to either IR or MR4. Period 3: MR4 in fed conditions. Receives: Drug: AZD1446 |
| Part 2: Extended/Modified release | Experimental | Extended/Modified release capsule to be determined Receives: Drug: AZD1446 |
| Part 2: Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Single Dose Administration :• Cmax, tmax, t½λz, AUC0-t, AUC, AUC0-τ (Part 2 only), Frel (Part 1 only), CL/F, Vz/F
Measured: Part 1 - 11 days
Part 2 Multiple Dose Administration: - Cmax, tmax, t½λz, AUC0-t, AUC, AUC0-τ (Part 2 only), Frel (Part 1 only), CL/F, Vz/F Day 9 of Part 2 following multiple dosing in addition to the above • Cmin, tmin, Cavg, fluctuation ratio, RCmax, RAUC(0-τ)
Measured: Part 2 - 10 days
Secondary outcomes (3)
Part 1: Safety and tolerabilty :- Laboratory safety data, vital signs, electrocardiogram, Columbia-Suicide Severity Rating Scale, adverse events, Mini-international neuropsychiatric interview
Measured: throughout the approx 7 weeks of study duration
Part 1: Single Dose Administration :• Cmax, tmax, t½λz, AUC0-t, AUC, AUC0-τ (Part 2 only), Frel (Part 1 only), CL/F, Vz/F
Measured: Part 1 - 11 days
Part 2 Multiple Dose Administration :- Cmax, tmax, t½λz, AUC0-t, AUC, AUC0-τ (Part 2 only), Frel (Part 1 only), CL/F, Vz/F Day 9 of Part 2 following multiple dosing in addition to the above • Cmin, tmin, Cavg, fluctuation ratio, RCmax, RAUC(0-τ
Measured: Part 2 - 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lena Bolin, Study director, AstraZeneca R&DAslak Rautio, Principal investigator, Quintiles Hermelinen ABWolfgang Kühn, Principal investigator, Quintiles AB, Phase I Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092299
- Sponsor's protocol ID
- D1950C00008
- Other IDs
- 2009-017702-36, 2009
- Status last verified
- Aug 2010
- First submitted
- 10 Mar 2010
- Last updated
- 27 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Investigate the Relative Bioavailability of Modified-release Formulations of AZD1446 Compared to an Immediate-release Capsule Under Fed and Fasting Conditions Following Single and Repeated Dose Administration to Young and Elderly Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01092299
- Acronym / sponsor ID
- D1950C00008
- Conditions
- Healthy
- Keywords
- Phase I, Relative bioavailability, Pharmacokinetic study, AZD1446, healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 24 Mar 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.
Part 1: The purpose of this study is to determine the pharmacokinetic profile of 4 different Extended/modified-release formulations and one immediate release formulation of AZD1446. In addition the food effect on AZD1446 pharmacokinetics will be investigated.
Part 2: To asses the safety and tolerability of the selected formulation(s) from part 1 in elderly healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (2 arms) | Experimental | Drug: AZD1446Period 1: randomized to either fasting IR or ER1. Period 2: Cross-over to either IR or ER1. Period 3: ER1 in fed conditions. |
| Cohort 2 (2 arms) | Experimental | Drug: AZD1446Period 1: randomized to either fasting IR or ER2. Period 2: Cross-over to either IR or ER2. Period 3: ER2 in fed conditions. |
| Cohort 3( 2 arms) | Experimental | Drug: AZD1446Period 1: randomized to either fasting IR or ER3. Period 2: Cross-over to either IR or ER3. Period 3: ER3 in fed conditions. |
| Cohort 4 (2 arms) | Experimental | Drug: AZD1446Period 1: randomized to either fasting IR or MR4. Period 2: Cross-over to either IR or MR4. Period 3: MR4 in fed conditions. |
| Part 2: Extended/Modified release | Experimental | Drug: AZD1446Extended/Modified release capsule to be determined |
| Part 2: Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body mass index (BMI) between 19 and 30 kg/m2
- Clinically normal findings on physical examination
Key exclusion criteria (3 listed)
- History of any clinically significant disease or disorder
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- History or present symptoms or signs of severe allergy/hypersensitivity reactions including severe food allergy, as judged by the investigator
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 |
|---|---|---|
| AZD1446ER Fast, 90mg, p.o. capsule | Drug | Cohort 1 (2 arms) |
| AZD1446ER Moderate, 90mg, p.o. capsule | Drug | Cohort 2 (2 arms) |
| AZD1446ER Slow, 90mg, p.o. capsule | Drug | Cohort 3( 2 arms) |
| AZD1446MR | Drug | Cohort 4 (2 arms), Part 2: Extended/Modified release |
| AZD1446IR, 90 mg p.o. capsule | Drug | Cohort 4 (2 arms), Part 2: Extended/Modified release |
| PlaceboIR | Drug | Part 2: Placebo |
| PlaceboER/MR | Drug | Part 2: Placebo |
Primary outcome
Part 1: Single Dose Administration :• Cmax, tmax, t½λz, AUC0-t, AUC, AUC0-τ (Part 2 only), Frel (Part 1 only), CL/F, Vz/F
Time frame: Part 1 - 11 days
Part 2 Multiple Dose Administration: - Cmax, tmax, t½λz, AUC0-t, AUC, AUC0-τ (Part 2 only), Frel (Part 1 only), CL/F, Vz/F Day 9 of Part 2 following multiple dosing in addition to the above • Cmin, tmin, Cavg, fluctuation ratio, RCmax, RAUC(0-τ)
Time frame: Part 2 - 10 days
3 secondary outcomes
Part 1: Safety and tolerabilty :- Laboratory safety data, vital signs, electrocardiogram, Columbia-Suicide Severity Rating Scale, adverse events, Mini-international neuropsychiatric interview
Time frame: throughout the approx 7 weeks of study duration
Part 1: Single Dose Administration :• Cmax, tmax, t½λz, AUC0-t, AUC, AUC0-τ (Part 2 only), Frel (Part 1 only), CL/F, Vz/F
Time frame: Part 1 - 11 days
Part 2 Multiple Dose Administration :- Cmax, tmax, t½λz, AUC0-t, AUC, AUC0-τ (Part 2 only), Frel (Part 1 only), CL/F, Vz/F Day 9 of Part 2 following multiple dosing in addition to the above • Cmin, tmin, Cavg, fluctuation ratio, RCmax, RAUC(0-τ
Time frame: Part 2 - 10 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 27 Aug 2010.
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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.
Lena Bolin study director
AstraZeneca R&D
Aslak Rautio principal investigator
Quintiles Hermelinen AB
Wolfgang Kühn principal investigator
Quintiles AB, Phase I Services
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD1446 in people with Healthy, run by AstraZeneca at 2 sites in Sweden.
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 3 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 27 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
Part 1: Single Dose Administration :• Cmax, tmax, t½λz, AUC0-t, AUC, AUC0-τ (Part 2 only), Frel (Part 1 only), CL/F, Vz/F (time frame: Part 1 - 11 days). The study lists 2 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 27 Aug 2010; AzTrials last refreshed its copy on 29 Oct 2026.