Healthy Participants
Conditions
Keywords
Glucagon-like peptide-1 receptor agonist, Anti-hyperglycemic, Pharmacokinetics (PK), Oral formulations, Formulation bridging, Weight management, Type 2 Diabetes Mellitus
Brief summary
The purpose of this study is to assess the pharmacokinetics (PK), safety and tolerability of different oral formulations of AZD5004, and to evaluate the effect of food on these formulations in healthy participants.
Detailed description
This is a Phase I, randomized, single-dose, 2 part, 3-period, open-label study. There will be 2 Parts (Part A and Part B). In each part, participants will be randomized to a treatment sequence in each cohort. In Period 1, participants in Part A and Part B will receive Regimen A (AZD5004 Formulation 1 \[reference\]). In Periods 2 and 3, participants in Part A will receive Regimen B or Regimen C (AZD5004 Formulation 5) and participants in Part B will receive Regimen D or Regimen E per assigned treatment sequence. The study will comprise: * A Screening Period of maximum 28 days * 3 Treatment Periods during which participants will be resident at the Clinical Unit * A final Follow-up Visit within 3 to 7 days after being discharged.
Interventions
DRUGAZD5004
AZD5004 will be administered orally.
Sponsors
AstraZeneca
Parexel
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Main Inclusion Criteria: * Participants suitable veins for cannulation or repeated venipuncture. * All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit. * Female participants: 1. of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception, to avoid pregnancy. 2. of non-childbearing potential must be confirmed at the Screening Visit. * Male participants: 1. Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods. 2. Additional contraception must be used for the sexual partners of male study participants throughout the clinical study. * Have a Body Mass Index (BMI) of ≥ 23 kg/m2 but not exceeding 35 kg/m2 inclusive (at the time of Screening) and weigh at least 60 kg. Main
Exclusion criteria
* History of any clinically important disease or disorder which, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study. * Any clinically significant illness, medical/surgical procedure, or trauma * Participants who have a special dietary requirement and who are unable/unwilling to follow a uniform diet. * Participants positive for anti- hepatitis B core antibody (anti-HBc) or anti-hepatitis C Virus Antibody (anti-HCV). * Participants who are on or are planning to undertake a weight loss program during the study period. * Abnormal vital signs, after 10 minutes supine rest, at Screening and/or admission to the Clinical Unit. * Positive screen for drugs of abuse, or alcohol or cotinine (nicotine). * Any laboratory values with the deviations specified in protocol and clinically important abnormalities in clinical chemistry, hematology, or urinalysis results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under concentration-time curve from time 0 extrapolated to infinity (AUCinf) | From Day 1 to Day 22 | To evaluate the PK (AUCinf) and assess the effect of food on the PK of different formulations of AZD5004 following single oral administration in healthy participants |
| Area under concentration-curve from time 0 to the time of last quantifiable concentration (AUClast) | From Day 1 to Day 22 | To evaluate the PK (AUClast) and assess the effect of food on the PK of different formulations of AZD5004 following single oral administration in healthy participants |
| Maximum observed concentration (Cmax) | From Day 1 to Day 22 | To evaluate the PK (Cmax) and assess the effect of food on the PK of different formulations of AZD5004 following single oral administration in healthy participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time of maximum observed concentration (tmax) | From Day 1 to Day 22 | To evaluate the PK (tmax) and assess the effect of food on the PK of different formulations of AZD5004 following single oral administration in healthy participants |
| Terminal rate constant (λz) | From Day 1 to Day 22 | To evaluate the PK (λz) and assess the effect of food on the PK of different formulations of AZD5004 following single oral administration in healthy participants |
| Terminal elimination half-life (t½λz) | From Day 1 to Day 22 | To evaluate the PK (t½λz) and assess the effect of food on the PK of different formulations of AZD5004 following single oral administration in healthy participants |
| Total body clearance calculated after a single extravascular administration where F (fraction of dose bioavailable) is unknown (CL/F) | From Day 1 to Day 22 | To evaluate the PK (CL/F) and assess the effect of food on the PK of different formulations of AZD5004 following single oral administration in healthy participants |
| Apparent volume of distribution based on the terminal phase calculated using AUC(0-inf) after a single extravascular administration where F (fraction of dose bioavailable) is unknown (Vz/F) | From Day 1 to Day 22 | To evaluate the PK (Vz/F) and assess the effect of food on the PK of different formulations of AZD5004 following single oral administration in healthy participants |
| Time of last measurable observed concentration (tlast) | From Day 1 to Day 22 | To evaluate the PK (tlast) and assess the effect of food on the PK of different formulations of AZD5004 following single oral administration in healthy participants |
| R AUC (Ratio of test treatment to reference based on AUC) | From Day 1 to Day 22 | To evaluate the PK (R AUC) and assess the effect of food on the PK of different formulations of AZD5004 following single oral administration in healthy participants |
| R Cmax (Ratio of test treatment to reference based on Cmax) | From Day 1 to Day 22 | To evaluate the PK (R Cmax) and assess the effect of food on the PK of different formulations of AZD5004 following single oral administration in healthy participants |
| F AUClast (Relative bioavailability based on AUClast) | From Day 1 to Day 22 | To evaluate the PK (F AUClast) of different formulations of AZD5004 following single oral administration in healthy participants |
| Number of participants with adverse events (AEs), serious AEs and AESIs (adverse events of special interest) | Up to Follow up (3 to 7 days after discharge) | To assess the safety and tolerability of different formulations of AZD5004 following single oral administration in healthy participants |
Countries
United States
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed