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AstraZenecaA Study to Investigate the Pharmacokinetics of Different Formulations and Safety of AZD5004 in Healthy Participants Aged 18 to 55 Years Phase 1 64
Clinical Trial NCT07455825 is designed to study Treatment for Healthy Participants. It is a Phase 1 interventional study that is recruiting, having started on March 5, 2026, with plans to enroll 64 participants. Led by AstraZeneca, it is expected to complete by June 1, 2026. The latest data from ClinicalTrials.gov was last updated on March 12, 2026.
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...
Show MoreOfficial Title
A Phase I, Randomized, Single-dose, 3-Period, Open-Label Study to Assess the Pharmacokinetic Formulation Bridging, Safety, and Food Effect of Different Oral Formulations of AZD5004 in Healthy Participants
Conditions
Healthy ParticipantsOther Study IDs
- D7260C00008
NCT ID Number
Start Date (Actual)
2026-03-05
Last Update Posted
2026-03-12
Completion Date (Estimated)
2026-06-01
Enrollment (Estimated)
64
Study Type
Interventional
PHASE
Phase 1
Status
Recruiting
Keywords
Glucagon-like peptide-1 receptor agonist
Anti-hyperglycemic
Pharmacokinetics (PK)
Oral formulations
Formulation bridging
Weight management
Type 2 Diabetes Mellitus
Anti-hyperglycemic
Pharmacokinetics (PK)
Oral formulations
Formulation bridging
Weight management
Type 2 Diabetes Mellitus
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalCohort A: Treatment Sequence ABC Participants will receive three treatments in sequence: Regimen A (formulation 1, fasted state), Regimen B (formulation 5, fasted state), followed by Regimen C (formulation 5, fed state) of AZD5004. | AZD5004 AZD5004 will be administered orally. |
ExperimentalCohort A: Treatment Sequence ACB Participants will receive three treatments in sequence: Regimen A (formulation 1, fasted state), Regimen C (formulation 5, fed state), followed by Regimen B (formulation 5, fasted state) of AZD5004. | AZD5004 AZD5004 will be administered orally. |
ExperimentalCohort B: Treatment Sequence ADE Participants will receive three treatments in sequence: Regimen A (formulation 1, fasted state), Regimen D (formulation 6, fasted state), followed by Regimen E (formulation 6, fed state). | AZD5004 AZD5004 will be administered orally. |
ExperimentalCohort B: Treatment Sequence AED Participants will receive three treatments in sequence: Regimen A (formulation 1, fasted state), Regimen E (formulation 6, fed state), followed by Regimen D (formulation 6, fasted state). | AZD5004 AZD5004 will be administered orally. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Area under concentration-time curve from time 0 extrapolated to infinity (AUCinf) | 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 | From Day 1 to Day 22 |
Area under concentration-curve from time 0 to the time of last quantifiable concentration (AUClast) | 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 | From Day 1 to Day 22 |
Maximum observed concentration (Cmax) | 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 | From Day 1 to Day 22 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Time of maximum observed concentration (tmax) | 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 | From Day 1 to Day 22 |
Terminal rate constant (λz) | 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 | From Day 1 to Day 22 |
Terminal elimination half-life (t½λz) | 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 | From Day 1 to Day 22 |
Total body clearance calculated after a single extravascular administration where F (fraction of dose bioavailable) is unknown (CL/F) | 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 | From Day 1 to Day 22 |
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) | 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 | From Day 1 to Day 22 |
Time of last measurable observed concentration (tlast) | 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 | From Day 1 to Day 22 |
R AUC (Ratio of test treatment to reference based on AUC) | 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 | From Day 1 to Day 22 |
R Cmax (Ratio of test treatment to reference based on Cmax) | 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 | From Day 1 to Day 22 |
F AUClast (Relative bioavailability based on AUClast) | To evaluate the PK (F AUClast) of different formulations of AZD5004 following single oral administration in healthy participants | From Day 1 to Day 22 |
Number of participants with adverse events (AEs), serious AEs and AESIs (adverse events of special interest) | To assess the safety and tolerability of different formulations of AZD5004 following single oral administration in healthy participants | Up to Follow up (3 to 7 days after discharge) |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
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:
- 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.
- of non-childbearing potential must be confirmed at the Screening Visit.
Male participants:
- Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.
- 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.
- 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.
AstraZenecaParexelStudy Central Contact
Contact: AstraZeneca Clinical Study Information Center, 1-877-240-9479, [email protected]
2 Study Locations in 1 Countries
California
Research Site, Glendale, California, 91206, United States
Recruiting
Maryland
Research Site, Baltimore, Maryland, 21225, United States
Not yet recruiting