Pharmacokinetics of Extended-Release Test- and Reference Formulations of AZD0837

NCT00878618 | Completed Phase 1

• 1 other identifier: D1250C00056
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of this study are to evaluate the pharmacokinetics, safety and tolerability of the oral doses of the extended-release test- and reference formulations of AZD0837 in healthy volunteers both in fasting and fed conditions.

Conditions

Healthy

Keywords

Healthy volunteers

Outcome Measures

Primary Outcomes (1)

• To evaluate the pharmacokinetics of AZD0837 and the active metabolite AR-H067637XX for the extended-release test formulation of AZD0837 compared to the ER reference formulation.

  Intense PK-sampling during 5 pre- defined study days for PK profiling. In 2 of the study days the subjects will have a breakfast before intake of the Investigational Product.

Secondary Outcomes (3)

• To evaluate the PK of the intermediate metabolite AR-H069927XX

  Since the metbolite will be evaluated from the AZD0837-samples the time frame is the same as above.

• Safety variables (ECG, pulse, blood pressure, safety lab, physical examination, adverse events)

  ECG & physical examination at start and end of study. Pulse and blood pressure predose day 1 and every day 2 h post dose. Adverse events collected during the whole study. Safety lab at a few timepoints but APTT will be checked on 4 h post dose on day 1.

• Measurement of plasma concentrations of 4 beta-hydroxycholesterol to investigate whether AZD0837 affects the level of CYP3A4

  Once predose on day 1, session 1 and once predose on day 5, session 2

Study Arms (4)

HAB

EXPERIMENTAL

AZD0837 test- (in session 1) and reference- (in session 2) formulation with heavy breakfast

Drug: AZD0837

HBA

EXPERIMENTAL

AZD0837 reference- (in session 1) and test- (in session 2) formulation with heavy breakfast

Drug: AZD0837

LAB

EXPERIMENTAL

AZD0837 test- (in session 1) and reference- (in session 2) formulation with light breakfast

Drug: AZD0837

LBA

EXPERIMENTAL

AZD0837 reference- (in session 1) and test- (in session 2) formulation with light breakfast

Drug: AZD0837

Interventions

AZD0837 DRUG

Extended-release tablets, test formulation. 2 tablets given in the morning for 6 days

HAB; LAB

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subject aged between 18 to 45 years inclusive
• Body mass index (BMI) between 19 to 30 kg/m2 inclusive
• Body weight between 50 to 100 kg inclusive
• Women must be either post-menopausal, permanently sterilised or, if of childbearing potential, must have a negative pregnancy test before intake of study medication and use a reliable form of contraception before and during participation in the study.

You may not qualify if:

• Significant illness (including ongoing or history of liver disease), trauma or surgical procedures from 2 weeks before the pre-entry visit until the first administration of Investigational Product
• Clinical significant abnormalities in clinical chemistry, haematology or urinalysis result including positive result on screening tests for serum hepatitis B surface antigen, hepatitis C antibody or HIV or positive F-Hb result pre-entry
• History of bleeding disturbance (including extensive menstrual bleedings) or thrombotic disorder
• Clinically significant medical history, as judged by the investigator, including psychiatric disorders or severe allergies.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Uppsala, Sweden

Location

MeSH Terms

Interventions

AZD 0837

Study Officials

• Elisabeth Edén Eden

  Quintiles AB, Uppsala, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 31, 2009
• First Posted: April 9, 2009
• Study Start: April 1, 2009
• Study Completion: May 1, 2009
• Last Updated: June 3, 2009

Record last verified: 2009-06

Locations

SE (1)