Healthy
Conditions
Keywords
Phase 1, bioavailability study, AZD1981, tablets, To study the relative bioavailability of single dose AZD1981 via three different tablets, To compare the bioavailability between three different AZD1981 tablets
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.
Interventions
DRUGAZD1981, current small-particle tablet
3x100 mg per oral, single dose in fasted state
DRUGAZD1981, new small-particle tablet
3x100 mg per oral, single dose
DRUGAZD1981, new large-particle table
3x100 mg per oral, single dose in fasted state
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Sweden
Outcome results
None listed