Healthy Participants, Pharmacokinetics
Conditions
Keywords
Evolocumab, AMG 145
Brief summary
The main objective of this trial is to evaluate the pharmacokinetics of two evolocumab drug products in healthy participants.
Interventions
DRUGEvolocumab Drug Substance A
Evolocumab drug substance A will be administered SC.
DRUGEvolocumab Drug Substance B
Evolocumab drug substance B will be administered SC.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female, of any race, between 18 and 60 years of age, inclusive. a. Females must not be pregnant or lactating. 2. Body Mass Index (BMI) between 18.0 and 32.0 kg/m\^2 inclusive. 3. LDL-C level ≥ 70 mg/dL (1.8 mmol/L) and ≤ 190 mg/dL (4.9 mmol/L) at screening.
Exclusion criteria
1. History or evidence of any clinically significant disorder, condition, or disease that in the opinion of the investigator (or designee) would pose a risk to participant safety or interfere with the trial evaluation, procedures, or completion. 2. History or current signs or symptoms of cardiovascular disease. 3. History or evidence of clinically significant arrhythmia. 4. History of hypersensitivity, intolerance, or allergy to evolocumab or its ingredients or other biological drugs. 5. Uncontrolled hyperthyroidism or hypothyroidism. 6. Current use or prior use of over-the-counter or other prescription medications, herbal medicines, vitamins, and supplements within 30 days or 5 half-lives prior to check-in. 7. Participation in another investigational device or drug trial within the past 30 days or 5 half-lives prior to check-in. 8. Have previously completed or withdrawn from this trial or any other trial investigating evolocumab, any other product directed against PCSK9, or have previously received evolocumab or PCSK9 inhibitor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Concentration-time Curve (AUC) from Time 0 Extrapolated to Infinity (AUCinf) of Evolocumab | Day 1 to Day 64 |
| Area Under the Concentration-time Curve from Time 0 to Time of Last Quantifiable Concentration (AUClast) of Evolocumab | Day 1 to Day 64 |
| Maximum Observed Concentration (Cmax) of Evolocumab | Day 1 to Day 64 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with Treatment-emergent Adverse Events | Day 1 to Day 64 |
| Number of Participants with Serious Adverse Events | Up to Day 64 |
| Number of Participants with Anti-evolocumab Antibody Formation | Day 1 and Day 64 |
| Area Under the Effect Curve From Day 1 through Day 64 (AUECDay1-Day64) of Low-density Lipoprotein Cholesterol (LDL-C) | Day 1 to Day 64 |
| Serum Levels of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) | Day 1 to Day 64 |
Countries
United States
Contacts
STUDY_DIRECTORMD
Amgen
Outcome results
None listed