A Bioavailability Study Comparing 3 Different AZD1981 Tablets

A Phase I, Open Label, Randomised, 4-way Crossover Study to Investigate the Relative Bioavailability of Single Dose AZD1981 Via 3 Different Tablets in Healthy Men and Healthy Women of Non-childbearing Potential

The purpose of this study is to study the relative bioavailability of AZD1981 when using a new tablet compared to the current tablet.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: AZD1981, current small-particle tablet; Drug: AZD1981, new small-particle tablet; Drug: AZD1981, new large-particle table

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male and postmenopausal or surgically sterile female volunteers aged 18-55, inclusive
• Have a body mass index between 19-30 kg/m2 and weigh at least 50 kg and no more than 100 kg, inclusive
• Be a non-smoker or ex-smoker who has stopped smoking for >6 months prior to screening
• Volunteers must be willing to use barrier methods of contraceptive, unless their partners are post-menopausal, surgically sterile or using accepted contraceptive methods.

Exclusion Criteria:

• Any clinically significant disease or disorder
• Any clinically relevant abnormal findings in the physical examination, clinical chemistry, haematology, urinalysis, vital signs (including body temperature), or ECG assessments at Visit 1, or in vital signs (including body temperature) at Visit 2
• Prolonged QTcF >450 ms or shortened QTcF<340 ms at Visit 1 or family history of long QT syndrome
• History of, or current alcohol or drug abuse

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment B	Drug: AZD1981, new small-particle tablet; 3x100 mg per oral, single dose
Experimental: Treatment C	Drug: AZD1981, new small-particle tablet; 3x100 mg per oral, single dose
Experimental: Treatment A	Drug: AZD1981, current small-particle tablet; 3x100 mg per oral, single dose in fasted state
Experimental: Treatment D	Drug: AZD1981, new large-particle table; 3x100 mg per oral, single dose in fasted state

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assessment of the area under the plasma concentration time-curve from zero to infinity /AUC) and the maximum plasma concentration (Cmax) of AZD1981	Pharmacokinetic (PK) sampling continuously for 60 h after each single dose, ie day 1-3 for each period.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate basic systemic PK parameters as follows:	AUC(0-t): area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration; tmax: time to reach Cmax; t1/2λz: terminal half-life; CL/F: apparent plasma clearance; MRT: apparent mean residence time; Vz/F: apparent volume of distribution during terminal phase	PK sampling continuously for 60 h after each single dose, ie day 1-3 for each period
To evaluate the safety and tolerability of AZD1981 by assessment of adverse events, laboratory safety parameters, vital signs, ECG, physical examination and weight		Safety will be monitored continuously and safety assessments will be made on several occasions throughout the whole study

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Wolfgang Kühn, MD, Quintiles AB, Phase 1 Services

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: March 3, 2011
• First Submitted That Met QC Criteria: March 8, 2011
• First Posted (Estimate): March 9, 2011

Study Record Updates

• Last Update Posted (Estimate): July 7, 2011
• Last Update Submitted That Met QC Criteria: July 6, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: Phase 1; tablets; bioavailability study; AZD1981; To study the relative bioavailability of single dose AZD1981 via three different tablets; To compare the bioavailability between three different AZD1981 tablets
• Other Study ID Numbers: D9830C00020