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AZD1446

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: Feb 17, 2011

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials7
Total Enrollment481
FDA Designations
No designations recorded
Clinical Trials (7)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01199315A Study to Assess the Safety, Tolerability and Pharmacokinetics of Modified-Release Formulations of AZD1446 After Oral Single and Repeated DosesPHASE1 COMPLETED 24 — — Sep 1, 2010Dec 1, 2010Feb 17, 20111 Japan
NCT01092299A Bioavailability Study Comparing Modified-release Capsules and Immediate Release Capsules in Fed and Fasting ConditionsPHASE1 COMPLETED 62 — — Feb 1, 2010Jul 1, 2010Aug 27, 20102 Sweden
NCT01021189Study to Assess Safety, Tolerability and Pharmacokinetics After Single and Multiple Doses of AZD1446 to Japanese SubjectPHASE1 COMPLETED 97 — — Dec 1, 2009Jun 1, 2010Jun 10, 20101 Japan
NCT00997308A Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD1446 Administered for 4 Weeks in Elderly Healthy VolunteersPHASE1 COMPLETED 97 — — Oct 1, 2009Dec 1, 2009Jan 22, 20101 Sweden
NCT00886067Positron Emission Tomography (PET) StudyPHASE1 COMPLETED 11 — — Apr 1, 2009Aug 1, 2009Sep 10, 20091 Sweden
NCT00902993Study to Investigate Safety, Tolerability and Pharmacokinetics With Single and Multiple Ascending Doses of AZD1446PHASE1 COMPLETED 80 — — Apr 1, 2009Sep 1, 2009Oct 1, 20092 Sweden
NCT00803855Study to Assess Safety, Tolerability and Pharmacokinetics After Single Doses of AZD1446 to Healthy VolunteersPHASE1 COMPLETED 110 — — Dec 1, 2008Apr 1, 2009May 15, 20091 Sweden
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Study Endpoints
Primary Endpoints
To assess safety and tolerability of AZD1446 following single and repeated doses of an orally administered MR capsule of AZD1446 in healthy young and elderly Japanese volunteers by adverse events, vital signs, laboratory variables and ECG.
During the whole study period, ca. 50 days
Part 1: Single Dose Administration :• Cmax, tmax, t½λz, AUC0-t, AUC, AUC0-τ (Part 2 only), Frel (Part 1 only), CL/F, Vz/F
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)
Part 2 - 10 days
To assess the safety and tolerability of AZD1446 following single and multiple ascending doses of an orally administered solution of AZD1446 in healthy young and elderly Japanese subjects by adverse events, vital signs, laboratory variables and ECG.
During the whole study period, ca. 50 days.
To assess the safety and tolerability of AZD1446 dosed for 4 weeks as compared to placebo in healthy elderly male and female volunteers. Safety and tolerability outcomes include adverse events, clinical chemistry and vitals (pulse and blood pressure).
During the whole study period, Study days 1-68 (30 days of enrolment , study day 1-28 and follow up visit study days 35-38).
Determine whether and to what extent AZD1446 can displace radioligand 2-[18F]-F-A85380 from binding to α4β2 neuronal nicotinic receptors (NNRs) and to describe the relationship between plasma concentrations of AZD1446 and its occupancy at α4β2 NNRs.
One PET assessment on baseline day and one PET assessment at the drug treatment day
Plasma concentration (Cmax, tmax, AUC)
During time period of the PET assessment
Part A: to assess the safety and tolerability of AZD1446 following multiple ascending doses of an orally administered solution of AZD1446 in male and non-fertile female, young and elderly Healthy Volunteers,
during the whole study period, ca 50 days
Part B: to assess the safety and tolerability of AZD1446 following administration of an oral solution of AZD1446 as fractionated doses during one day in male and non-fertile female, young and elderly Healthy Volunteers.
during the whole study period, ca 43 days
Safety and tolerability of AZD1446 by assessment of serious adverse events, ECGs, vital signs and laboratory variables
From first to last visit
Secondary Endpoints
To determine PK of AZD1446 following single and repeated doses of AZD1446 MR capsule in healthy young and elderly Japanese volunteers.
PK samplings are taken at defined timepoints during residential period, 10 days.
Part 1: Safety and tolerabilty :- Laboratory safety data, vital signs, electrocardiogram, Columbia-Suicide Severity Rating Scale, adverse events, Mini-international neuropsychiatric interview
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
Part 1 - 11 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
1EXPERIMENTALOral capsule. Dose single and followed by 5-day repeated dosing. Specific doses depend on panel.
2PLACEBO_COMPARATOROral capsule. Dose single and followed by 5-day repeated dosing.
Cohort 1 (2 arms)EXPERIMENTALPeriod 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)EXPERIMENTALPeriod 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)EXPERIMENTALPeriod 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)EXPERIMENTALPeriod 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 releaseEXPERIMENTALExtended/Modified release capsule to be determined
Part 2: PlaceboPLACEBO_COMPARATOR -
AZD1446 LowEXPERIMENTALLow dose of AZD1446
AZD1446 HighEXPERIMENTALHigh dose of AZD1446
PlaceboPLACEBO_COMPARATOR -
2-[18F]-F-A85380EXPERIMENTALSingle microdose
AZD1446EXPERIMENTALSingle oral administration
AZD1446 Oral or placeboEXPERIMENTALSingle oral administration of AZD1446 or placebo
AZD1446 Oral, with or without foodEXPERIMENTALSingle oral administration of AZD1446 with or without food
Interventions
NameTypeDescription
AZD1446DRUGoral capsule, Moderate Release
PlaceboDRUGoral capsule
2-[18F]-F-A85380RADIATIONiv, single dose
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Eligibility Criteria
Age Range20 Years — 80 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy Japanese volunteers, aged ≥20 to ≤50 years for male young volunteers, ≥65 to ≤80 years for male or post-menopausal female elderly volunteers. * BMI between 18 and 27 kg/m2 and weigh at least 50 kg and no more than 90 kg (for the elderly female, weigh at least 45 kg and...

Countries:JapanSweden
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