The purpose of this study is to assess the pharmacokinetics (PK) and safety of AZD2389 when administered alone and in combination with quinidine in healthy participants.
This is a 2-way cross-over study to evaluate the effect of quinidine on the PK of AZD2389. The study will include 2 Treatments - Treatment A - AZD2389 Treatment B - AZD2389 + quinidine The study will comprise - 1. A Screening Period of maximum 28 days. 2. Period 1: single dose administration of Treatment A or Treatment B on Day 1. Period 2 will start after a washout period of at least 7 days. 3. Period 2: single dose of alternate treatment on Day 8. 4. A Follow-up Visit: participants will return for a Follow-up Visit, 7 to 14 days after the last AZD2389 PK sample in Period 2. Participants will be randomized to one of the 2 treatment sequences - 1. Sequence AB: Treatment A in Period 1, Treatment B in Period 2. 2. Sequence BA: Treatment B in Period 1, Treatment A in Period 2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Research Site
Brooklyn, Maryland, United States
Ratio of Test treatment (AZD2389 + quinidine) to Reference treatment (AZD2389) based on maximum observed plasma concentration (RCmax)
To assess the effect of quinidine on the PK of AZD2389.
Time frame: Day 1 to Day 10
Ratio of Test treatment (AZD2389 + quinidine) to Reference treatment (AZD2389) based on area under concentration-time curve from time 0 to infinity (RAUCinf)
To assess the effect of quinidine on the PK of AZD2389.
Time frame: Day 1 to Day 10
Ratio of Test treatment (AZD2389 + quinidine) to Reference treatment (AZD2389) based on area under concentration-time curve from time 0 to the last quantifiable concentration (RAUClast)
To assess the effect of quinidine on the PK of AZD2389.
Time frame: Day 1 to Day 10
Apparent total body clearance (CL/F) of AZD2389
To assess the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.
Time frame: Day 1 to Day 10
Volume of distribution (apparent) following extravascular administration (based on terminal phase) (Vz/F) of AZD2389
To assess the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.
Time frame: Day 1 to Day 10
Terminal elimination half-life (t1/2λz) of AZD2389
To assess the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.
Time frame: Day 1 to Day 10
Time to reach maximum observed concentration (tmax) of AZD2389
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To assess the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.
Time frame: Day 1 to Day 10
Maximum observed plasma concentration (Cmax) of AZD2389
To assess the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.
Time frame: Day 1 to Day 10
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) of AZD2389
To assess the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.
Time frame: Day 1 to Day 10
Area under concentration-time curve from time zero to infinity (AUCinf) of AZD2389
To assess the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.
Time frame: Day 1 to Day 10
Renal Clearance (CLR) of AZD2389 from plasma
To assess the urine PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.
Time frame: Day 1 to Day 10
Individual and cumulative percentage of dose excreted unchanged in urine from time t1 to time t2 (fe[t1-t2]) of AZD2389
To assess the urine PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.
Time frame: Day 1 to Day 10
Individual and cumulative amount of unchanged drug excreted into urine from time t1 to time t2 (Ae[t1-t2]) of AZD2389
To assess the urine PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.
Time frame: Day 1 to Day 10
Percent change from baseline in fibroblast activation protein (FAP) inhibition
To assess the pharmacodynamics (PD) of AZD2389 by assessment of inhibition of FAP activity in plasma after single oral dose of AZD2389 alone or in combination with quinidine.
Time frame: Baseline, Day 1 to Day 10
Number of participants with Adverse Events (AEs)
To assess the safety and tolerability of a single oral dose of AZD2389 alone or in combination with quinidine in healthy participants.
Time frame: From Screening (Day -28 to Day -2) to Follow-up visit (upto 8 weeks)