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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014