The purpose of the study is to assess the effect of AZD5004 on the pharmacokinetics (PK) of mitiglinide and pioglitazone in healthy participants.
This is an open-label, fixed-sequence, two-part study of mitiglinide (Part A) and pioglitazone (Part B) in healthy participants. Part A will assess the PK of mitiglinide when administered alone and in combination with AZD5004 while Part B will assess the PK of pioglitazone when administered alone and in combination of AZD5004. Both parts are independent and non-sequential to each other. Each study part will comprise of: 1. A screening period of maximum 28 days. 2. Four sequential treatment periods during which the participants will receive the study interventions. 3. A final follow-up visit
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
AZD5004 will be administered orally.
Mitiglinide will be administered orally.
Pioglitazone will be administered orally.
Research Site
Fukuoka, Japan
RECRUITINGArea under concentration-time curve from time 0 to infinity (AUCinf)
To assess the effect of AZD5004 on the PK (AUCinf) of mitiglinide and pioglitazone in healthy participants
Time frame: Part A: From Day 1 to Day 50; Part B: From Day 1 to Day 70
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
To assess the effect of AZD5004 on the PK (AUClast) of mitiglinide and pioglitazone in healthy participants
Time frame: Part A: From Day 1 to Day 50; Part B: From Day 1 to Day 70
Maximum observed drug concentration (Cmax)
To assess the effect of AZD5004 on the PK (Cmax) of mitiglinide and pioglitazone in healthy participants
Time frame: Part A: From Day 1 to Day 50; Part B: From Day 1 to Day 70
Number of participants with adverse events (AEs) and AE of special interest (AESI)
To examine the safety and tolerability of AZD5004 alone and in combination with mitiglinide and pioglitazone in healthy participants
Time frame: Part A: Up to follow-up visit [Day 54 (± 3 days)]; Part B: Up to follow-up visit [Day 74 (± 3 days)]
Terminal elimination half-life (t½λz)
To assess the effect of AZD5004 on the PK (t½λz) of mitiglinide and pioglitazone in healthy participants
Time frame: Part A: From Day 1 to Day 50; Part B: From Day 1 to Day 70
Terminal rate constant (λz)
To assess the effect of AZD5004 on the PK (λz) of mitiglinide and pioglitazone in healthy participants
Time frame: Part A: From Day 1 to Day 50; Part B: From Day 1 to Day 70
AstraZeneca Clinical Study Information Center
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Time to reach maximum observed concentration (tmax)
To assess the effect of AZD5004 on the PK (tmax) of mitiglinide and pioglitazone in healthy participants
Time frame: Part A: From Day 1 to Day 50; Part B: From Day 1 to Day 70
Part A: Ratio of mitiglinide + AZD5004 to mitiglinide (alone) based on AUCinf (RAUCinf)
To assess the effect of AZD5004 on the PK (RAUCinf) of mitiglinide in healthy participants
Time frame: From Day 1 to Day 50
Part A: Ratio of mitiglinide + AZD5004 to mitiglinide (alone) based on AUClast (RAUClast)
To assess the effect of AZD5004 on the PK (RAUClast) of mitiglinide in healthy participants
Time frame: From Day 1 to Day 50
Part A: Ratio of mitiglinide + AZD5004 to mitiglinide (alone) based on Cmax (RCmax)
To assess the effect of AZD5004 on the PK (RCmax) of mitiglinide in healthy participants
Time frame: From Day 1 to Day 50
Part B: Ratio of pioglitazone + AZD5004 to pioglitazone (alone) based on AUCinf (RAUCinf)
To assess the effect of AZD5004 on the PK (RAUCinf) of pioglitazone in healthy participants
Time frame: From Day 1 to Day 70
Part B: Ratio of pioglitazone + AZD5004 to pioglitazone (alone) based on AUClast (RAUClast)
To assess the effect of AZD5004 on the PK (RAUClast) of pioglitazone in healthy participants
Time frame: From Day 1 to Day 70
Part B: Ratio of pioglitazone + AZD5004 to pioglitazone (alone) based on Cmax (RCmax)
To assess the effect of AZD5004 on the PK (RCmax) of pioglitazone in healthy participants
Time frame: From Day 1 to Day 70