Healthy Participants Clinical Trial
Official title:
A Phase I Randomized Single-blind Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD6234 Following Single Ascending Dose Administration to Healthy Subjects Who Are Overweight or Obese
A study in healthy male and female participants of non-childbearing potential who are overweight or obese.
The study will comprise of: - A Screening Period of maximum 28 days. - A Treatment Period during which participants will be resident at the Clinical Unit from three days before (Day -3 ) Investigational Medicinal Product (IMP) administration (Day 1) until at least 4 days (96 hours) after IMP administration, participants will then be discharged on the morning of Day 5. - Weekly outpatient visits on Days 8, 15, 22, 29, and 36 for blood sample collection, Electrocardiogram (ECGs), and adverse events (AE) recording. - A Follow-up Visit 6 weeks (Day 43) after the last IMP dose. Furthermore, 3 dose levels of AZD6234 for Subcutaneous (SC) administration (Cohorts 1 to 3) and one dose level for Intravenous (IV) administration (Cohort 4) are planned to be investigated in healthy participants who are overweight or obese. The IV cohort (Cohort 4) can begin in parallel or after Cohort 3. One dose level for SC administration is planned to be investigated in Japanese participants only (Cohort 5), and up to 3 additional dose levels for SC administration are planned to be investigated in healthy participants (Cohort 6 to 8). Depending on the findings, additional (optional) dose level cohorts may be added at the discretion of the Sponsor. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05445440 -
A Study to Assess the Effects of BMS-986371 on the Drug Levels of Methotrexate in the Presence and Absence of Sulfasalazine
|
Phase 1 | |
| Completed |
NCT03712540 -
An Investigational Study of Experimental Medication BMS-986278 Given With the Antibiotic Rifampin in Healthy Participants
|
Phase 1 | |
| Completed |
NCT03649165 -
A Study to Evaluate Bioavailability and Food Effect of Selumetinib (AZD6244) in Healthy Male Participants
|
Phase 1 | |
| Completed |
NCT05956002 -
A Study to Evaluate the Study Medication (Etrasimod) When Mixed With Food in Healthy Participants
|
Phase 1 | |
| Completed |
NCT05539976 -
A Taste Assessment of Iberdomide and Mezigdomide in Healthy Participants
|
||
| Withdrawn |
NCT04558216 -
Evaluation of Effect of Rifampin on the Pharmacokinetics of Vonoprazan in Healthy Participants
|
Phase 1 | |
| Withdrawn |
NCT03007771 -
Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia
|
Phase 1 | |
| Completed |
NCT06097390 -
A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation III
|
Phase 1 | |
| Completed |
NCT05546151 -
A Study to Assess the Safety and Tolerability of BMS-986322 in Healthy Participants of Japanese Descent
|
Phase 1 | |
| Completed |
NCT05056246 -
Study of AMG 133 Administered Subcutaneously in Healthy Japanese and Caucasian Participants
|
Phase 1 | |
| Completed |
NCT04390776 -
Bioequivalence Study of PF-06651600 Capsules Relative to Tablets and Estimation of Food Effect on Capsules.
|
Phase 1 | |
| Completed |
NCT05074459 -
A Study in Healthy Adults Investigating Eptinezumab Produced by 2 Different Manufacturing Cell Lines
|
Phase 1 | |
| Enrolling by invitation |
NCT06089109 -
Creating VIP Corps to Reduce Maternal Deaths
|
N/A | |
| Completed |
NCT05996250 -
Tolerance of an Immersive Virtual Reality Task Evaluating the Spatial Memory of Elderly Subjects
|
N/A | |
| Completed |
NCT03278080 -
Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #1
|
N/A | |
| Completed |
NCT05064800 -
PF-07321332/Ritonavir and Ritonavir on Dabigatran Study in Healthy Participants
|
Phase 1 | |
| Completed |
NCT04471298 -
A Study of Qishenyiqi Dripping Pills in Healthy Participants
|
Phase 1 | |
| Completed |
NCT04914936 -
A Study to Evaluate the One-way Interaction of Calcium Carbonate, Omeprazole, or Rifampin on ACP-196
|
Phase 1 | |
| Completed |
NCT02882386 -
Amino Acid Kinetics in Blood After Consuming Different Milk Protein Supplements
|
N/A | |
| Completed |
NCT01681186 -
A Study of LY2940680 in Healthy Participants
|
Phase 1 |