Healthy Participants
Conditions
Keywords
Pharmacokinetics, Type 2 Diabetes, Obesity
Brief summary
The purpose of the study is to assess the effect of AZD5004 on the pharmacokinetics (PK) of mitiglinide and pioglitazone in healthy participants.
Detailed description
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
Interventions
DRUGAZD5004
AZD5004 will be administered orally.
DRUGMitiglinide
Mitiglinide will be administered orally.
DRUGPioglitazone
Pioglitazone will be administered orally.
Sponsors
AstraZeneca
Parexel
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants with suitable veins for cannulation or repeated venipuncture. * All females must have a negative serum pregnancy test at the Screening Visit and on admission to the study site. * Females of childbearing potential must agree to use a highly effective contraception method from enrollment. * Male Participants, if heterosexually active, must practice true abstinence or use condoms during the trial and their female partners of childbearing potential must use additional effective contraception during the trial. * Body Mass Index (BMI) between 18 and 35 kg/m² and weigh at least 50 kg.
Exclusion criteria
* History of any clinically important disease or disorder which may put the participant at risk or influence the results, including: 1. Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper gastrointestinal (GI) tract 2. Cardiovascular disease 3. Neuromuscular or neurogenic disease 4. Type 1 or type 2 diabetes mellitus * History of acute pancreatitis, chronic pancreatitis, gallstones, or elevation in serum lipase/pancreatic amylase. * History of clinically significant cardiovascular, dermatological, respiratory, neurological, psychiatric or GI disease disorder. * History of malignant neoplastic disease. * History or presence of GI disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. * Any clinically important illness, medical/surgical procedure, or trauma. * Any clinically important abnormalities in clinical chemistry, hematology, coagulation, or urinalysis results. * Basal calcitonin level ≥ 35 ng/L or history/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (MEN2). * Uncontrolled thyroid disease. * Any positive result on screening for serum human immunodeficiency virus (HIV). * Known or suspected history of alcohol or drug abuse or excessive intake of alcohol. * History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity to drugs with a similar chemical structure or class to AZD5004, or to mitiglinide and/or pioglitazone. * Participants who have previously received AZD5004.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under concentration-time curve from time 0 to infinity (AUCinf) | Part A: From Day 1 to Day 50; Part B: From Day 1 to Day 70 | To assess the effect of AZD5004 on the PK (AUCinf) of mitiglinide and pioglitazone in healthy participants |
| Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) | Part A: From Day 1 to Day 50; Part B: From Day 1 to Day 70 | To assess the effect of AZD5004 on the PK (AUClast) of mitiglinide and pioglitazone in healthy participants |
| Maximum observed drug concentration (Cmax) | Part A: From Day 1 to Day 50; Part B: From Day 1 to Day 70 | To assess the effect of AZD5004 on the PK (Cmax) of mitiglinide and pioglitazone in healthy participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events (AEs) and AE of special interest (AESI) | Part A: Up to follow-up visit [Day 54 (± 3 days)]; Part B: Up to follow-up visit [Day 74 (± 3 days)] | To examine the safety and tolerability of AZD5004 alone and in combination with mitiglinide and pioglitazone in healthy participants |
| Terminal elimination half-life (t½λz) | Part A: From Day 1 to Day 50; Part B: From Day 1 to Day 70 | To assess the effect of AZD5004 on the PK (t½λz) of mitiglinide and pioglitazone in healthy participants |
| Terminal rate constant (λz) | Part A: From Day 1 to Day 50; Part B: From Day 1 to Day 70 | To assess the effect of AZD5004 on the PK (λz) of mitiglinide and pioglitazone in healthy participants |
| Time to reach maximum observed concentration (tmax) | Part A: From Day 1 to Day 50; Part B: From Day 1 to Day 70 | To assess the effect of AZD5004 on the PK (tmax) of mitiglinide and pioglitazone in healthy participants |
| Part A: Ratio of mitiglinide + AZD5004 to mitiglinide (alone) based on AUCinf (RAUCinf) | From Day 1 to Day 50 | To assess the effect of AZD5004 on the PK (RAUCinf) of mitiglinide in healthy participants |
| Part A: Ratio of mitiglinide + AZD5004 to mitiglinide (alone) based on AUClast (RAUClast) | From Day 1 to Day 50 | To assess the effect of AZD5004 on the PK (RAUClast) of mitiglinide in healthy participants |
| Part A: Ratio of mitiglinide + AZD5004 to mitiglinide (alone) based on Cmax (RCmax) | From Day 1 to Day 50 | To assess the effect of AZD5004 on the PK (RCmax) of mitiglinide in healthy participants |
| Part B: Ratio of pioglitazone + AZD5004 to pioglitazone (alone) based on AUCinf (RAUCinf) | From Day 1 to Day 70 | To assess the effect of AZD5004 on the PK (RAUCinf) of pioglitazone in healthy participants |
| Part B: Ratio of pioglitazone + AZD5004 to pioglitazone (alone) based on AUClast (RAUClast) | From Day 1 to Day 70 | To assess the effect of AZD5004 on the PK (RAUClast) of pioglitazone in healthy participants |
| Part B: Ratio of pioglitazone + AZD5004 to pioglitazone (alone) based on Cmax (RCmax) | From Day 1 to Day 70 | To assess the effect of AZD5004 on the PK (RCmax) of pioglitazone in healthy participants |
Countries
Japan
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed