A Bioavailability Study Comparing 3 Different AZD1981 Tablets

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD1981, new small-particle tablet; Drug: AZD1981, current small-particle tablet; Drug: AZD1981, new large-particle table

• Registration Number: NCT01311635
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-03
• Study First Submitted QC: 2011-03-08
• Study First Posted: 2011-03-09
• Study Start: 2011-04
• Primary Completion: 2011-05
• Study Completion: 2011-06
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-06
• Last Update Posted: 2011-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment B	AZD1981, new small-particle tablet	-
Treatment C	AZD1981, new small-particle tablet	-
Treatment A	AZD1981, current small-particle tablet	-
Treatment D	AZD1981, new large-particle table	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
To evaluate basic systemic PK parameters as follows:	PK sampling continuously for 60 h after each single dose, ie day 1-3 for each period	* 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
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

Trial Locations

Locations (1)

Research Site; 🇸🇪 Uppsala, Sweden