A Bioavailability Study Comparing 3 Different AZD1981 Tablets

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01311635
• Other study ID #: D9830C00020
• Status: Completed
• Phase: Phase 1
• First received: March 3, 2011
• Last updated: July 6, 2011
• Start date: April 2011
• Est. completion date: June 2011

Study information

• Verified date: July 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• AZD1981, current small-particle tablet
3x100 mg per oral, single dose in fasted state
• AZD1981, new small-particle tablet
3x100 mg per oral, single dose
• AZD1981, new large-particle table
3x100 mg per oral, single dose in fasted state

Locations

Country	Name	City	State
Sweden	Research Site	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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; t1/2?z: 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	No
Secondary	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	Yes