A Bioavailability Study Comparing Modified-release Capsules and Immediate Release Capsules in Fed and Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01092299
First received: March 10, 2010
Last updated: August 26, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: AZD1446
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: February 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1 (2 arms)
Period 1: randomized to either fasting IR or ER1. Period 2: Cross-over to either IR or ER1. Period 3: ER1 in fed conditions.
Drug: AZD1446
ER Fast, 90mg, p.o. capsule
Experimental: Cohort 2 (2 arms)
Period 1: randomized to either fasting IR or ER2. Period 2: Cross-over to either IR or ER2. Period 3: ER2 in fed conditions.
Drug: AZD1446
ER Moderate, 90mg, p.o. capsule
Experimental: Cohort 3( 2 arms)
Period 1: randomized to either fasting IR or ER3. Period 2: Cross-over to either IR or ER3. Period 3: ER3 in fed conditions.
Drug: AZD1446
ER Slow, 90mg, p.o. capsule
Experimental: Cohort 4 (2 arms)
Period 1: randomized to either fasting IR or MR4. Period 2: Cross-over to either IR or MR4. Period 3: MR4 in fed conditions.
Drug: AZD1446
MR
Drug: AZD1446
IR, 90 mg p.o. capsule
Experimental: Part 2: Extended/Modified release
Extended/Modified release capsule to be determined
Drug: AZD1446
MR
Drug: AZD1446
IR, 90 mg p.o. capsule
Placebo Comparator: Part 2: Placebo Drug: Placebo
IR
Drug: Placebo
ER/MR

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body mass index (BMI) between 19 and 30 kg/m2
  • Clinically normal findings on physical examination

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01092299

Locations
Sweden
Research Site
Lulea, Sweden
Research Site
Uppsala, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Lena Bolin AstraZeneca R&D
Principal Investigator: Aslak Rautio Quintiles Hermelinen AB
Principal Investigator: Wolfgang Kühn Quintiles AB, Phase I Services
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01092299     History of Changes
Other Study ID Numbers: D1950C00008, 2009-017702-36
Study First Received: March 10, 2010
Last Updated: August 26, 2010
Health Authority: Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
Phase I
Relative bioavailability
Pharmacokinetic study
AZD1446
healthy volunteers

ClinicalTrials.gov processed this record on April 16, 2014