A Study to Investigate Multiple Ascending Doses of AZD5004 in Healthy Japanese Participants and Participants With Type 2 Diabetes Mellitus
NCT06703658 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2025-03-21
Summary
This Phase I study will gather important information on the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5004 in both healthy Japanese participants and Japanese participants with T2DM.
Conditions
- Healthy Participants
- Type 2 Diabetes
Interventions
- DRUG
-
AZD5004(Part A)
Single dose of AZD5004 oral on Day1
- DRUG
-
Placebo(Part A)
Single dose of placebo oral on Day1
- DRUG
-
AZD5004(Part B)
AZD5004 will be administered as an oral tablet once daily.
- DRUG
-
Placebo(Part B)
Placebo will be administered as an oral tablet once daily.
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-11-02
- Primary Completion
- 2025-03-13
- Completion
- 2025-03-13
Countries
- Japan
Study Locations
More Related Trials
-
A Study to Assess Safety, Tolerability, and Pharmacokinetics of AZD0186
NCT05694741 ·Status: TERMINATED ·Phase: PHASE1
-
MK-1006 Single Dose Study in Japanese Type 2 Diabetes Patients (MK-1006-005)
NCT00791661 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate Safety, Tolerability and P-Glucose After Multiple Ascending Oral Doses of AZD1656 in Type 2 Diabetes
NCT00747175 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus
NCT01023945 ·Status: COMPLETED ·Phase: PHASE1
-
Phase IV Study With a 36-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin Therapy When Added to the Therapy of Japanese Patients With Type 2 Diabetes With Inadequate Glycemic Control on Insulin.
NCT02157298 ·Status: COMPLETED ·Phase: PHASE4
-
Single Ascending Dose Study With Healthy Male Volunteers and Type II Diabetic Patients
NCT00886366 ·Status: TERMINATED ·Phase: PHASE1
-
Phase I Multiple-Ascending Dose (Japan)
NCT00538174 ·Status: COMPLETED ·Phase: PHASE1
-
To Evaluate Safety and Tolerability After Multiple Oral Doses of AZD1656 in Type 2 Diabetes Patients on Top of Metformin
NCT00774553 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Tolerability After Four Weeks of Treatment With AZD1656 in Patients With Type 2 Diabetes
NCT00856908 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of LY3502970 in Japanese Participants With Type 2 Diabetes Mellitus
NCT05086445 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Tolerability Study of MEDI0382 in Japanese Preobese or Obese Subjects With Type 2 Diabetes
NCT03645421 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics After High Single Ascending Oral Doses of AZD1656 in T2DM Patients
NCT01221545 ·Status: COMPLETED ·Phase: PHASE1
-
Assessment of the Safety, Tolerability and Pharmacodynamics After Administration of One Dose of AZD8601 to Male Patients With Type II Diabetes Mellitus (T2DM)
NCT02935712 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of LY3209590 in Japanese Participants With Type 2 Diabetes
NCT03603704 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy, Safety, and Tolerability of Once Daily Oral Administration of AZD5004 Versus Placebo for 26 Weeks in Adults With Type 2 Diabetes Mellitus.
NCT06579105 ·Status: COMPLETED ·Phase: PHASE2
-
The Safety and Efficacy of Dapagliflozin Therapy in Combination With Insulin in Japanese Subjects With T1DM
NCT02582814 ·Status: COMPLETED ·Phase: PHASE3
-
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 44847 in Female and Male Patients With Type 2 Diabetes
NCT02211963 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess the Efficacy and Safety of ASP1941 in Japanese Type 2 Diabetes Patients
NCT01057628 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase 1 Trial to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-3167 Single Injection in Healthy Subjects and Patients With Type 2 Diabetes
NCT05996380 ·Status: UNKNOWN ·Phase: PHASE1
-
A First-time-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of GSK189075A in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus
NCT01571661 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of LY3549492 in Japanese Participants With Type 2 Diabetes Mellitus (T2D) and Healthy Japanese Participants
NCT06869018 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of ZT002 Injection in Adult Chinese Subjects With Type 2 Diabetes Mellitus (T2DM)
NCT07065032 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
BI 1356 BS in Japanese Patients With Type 2 Diabetes Mellitus
NCT02183324 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase 1 Study In Japanese Subjects With Type 2 Diabetes Mellitus As Monotherapy
NCT02292433 ·Status: COMPLETED ·Phase: PHASE1
-
Dose Response Study in Japanese Patients
NCT00261417 ·Status: TERMINATED ·Phase: PHASE2