Overweight, Obesity
Conditions
Keywords
Antiemetic, Drug-drug Interaction, AMG 133, Ondansetron, Overweight, Obesity
Brief summary
The primary objective of this trial is to evaluate the pharmacokinetics (PK) of AMG 133 administered alone and in combination with an antiemetic medication, ondansetron, in participants living with overweight or obesity.
Interventions
DRUGAMG 133
AMG 133 will be administered SC.
DRUGOndansetron
Ondansetron will be administered via ODT.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female participants, between 18 and 65 years of age. 2. Body mass index \> 25 kg/m\^2.
Exclusion criteria
1. History or evidence of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the Investigator, would pose a risk to participant safety or interfere with the trial evaluation, procedures, or completion. 2. History of or active diabetes or hemoglobin A1C \> 6.5%. 3. History or evidence of endocrine disorder. 4. History of acute or chronic pancreatitis within 1 year, or elevation in serum lipase/amylase (\> 2 x upper limit of normal \[ULN\]), or fasting serum triglyceride level of \> 500 mg/dL. 5. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2. 6. Uncontrolled thyroid disease. 7. History or current signs or symptoms of cardiovascular disease. 8. A QT interval corrected for heart rate based on the Fridericia's method (QTcF) interval \> 450 msec in male participants or \> 470 msec in female participants or history/evidence of long QT syndrome. 9. History of hypersensitivity, intolerance, or allergy to AMG 133 or its ingredients. 10. Any contraindication to ondansetron ODT according to the applicable labelling. 11. Alanine aminotransferase or aspartate aminotransferase \> 2 x the ULN. 12. Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before check-in. 13. Current use or prior use of any glucagon-like peptide 1 receptor (GLP-1R) agonist, or glucose-dependent insulinotropic polypeptide receptor (GIPR) agonist or antagonist within the past 3 months. 14. Participant has received a dose of an investigational medicinal product (IMP) within the past 30 days or 5 half-lives. 15. Have previously completed or withdrawn from this trial or any other trial investigating AMG 133 or have previously received the IMP.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Observed Plasma Concentration (Cmax) of AMG 133 | Up to Day 120 |
| Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of AMG 133 | Up to Day 120 |
| AUC from Time Zero to Infinity (AUCinf) of AMG 133 | Up to Day 120 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) | Up to Day 120 |
| Number of Participants with Serious AEs (SAEs) | Up to Day 120 |
| Number of Participants with Anti-AMG 133 Antibodies | Up to Day 120 |
Countries
United States
Outcome results
None listed