NCT07455825CompletedPhase 1
A Study to Investigate the Pharmacokinetics of Different Formulations and Safety of AZD5004 in Healthy Participants Aged 18 to 55 Years
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
Source: ClinicalTrials.gov · Last updated 10 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 65 (actual)
- First submitted
- 3 Mar 2026
- Start date
- 5 Mar 2026
- Primary completion date
- 1 Jun 2026
- Lead sponsor
- AstraZeneca
- Diseases
- Type 2 diabetes
- NCT number
- NCT07455825
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 65
- From 5 Mar 2026 to the primary completion date, 1 Jun 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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:
- 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.
- 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.
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Glendale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.