Healthy Volunteers
Conditions
Keywords
Pharmacokinetics, Healthy Volunteer
Brief summary
The main objective of the study is to assess the safety and tolerability of AMG 378 as single or multiple doses in healthy participants.
Interventions
DRUGAMG 378
Oral tablet
DRUGPlacebo
Oral tablet
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Intervention model description
The food-effect cohort will have a cross-over design with 2 periods.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female participants ≥ 18 to ≤ 55 years (inclusive) at the time of signing the informed consent. * Body mass index between 18 and 30 kg/m\^2, inclusive, at screening. * Men (even with a history of vasectomy) with partners of childbearing potential must agree to practice sexual abstinence or use a male barrier method of contraception (ie, male condom with spermicide) in addition to a second method of acceptable contraception by female partner from Check-in until 30 days after the last dose of investigational product. * Participant must be overtly healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, vital signs, physical examination, laboratory tests, and 12-lead electrocardiogram (ECG) recording(s) at the screening and Day 1 visits.
Exclusion criteria
* History of malignancy of any type. * History of esophageal, gastric, or duodenal ulceration prior to screening visit. * Evidence of active bacterial, viral, fungal or parasitic infections within the last 30 days prior to study Day 1. * History or evidence of clinically significant arrhythmia at screening, or Day 1 ECG. * A QT interval corrected for heart rate (HR) based on the Fridericia method (QTcF) interval \> 450 ms in all participants regardless of biological sex or history/evidence of long QT syndrome at screening or study Day -1. * Positive results for human immunodeficiency virus (HIV) antibodies, HIV antigen, hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C virus ribonucleic acid (RNA) at screening. * History of active tuberculosis (TB) infection, current symptoms concerning for active TB, or positive or indeterminate interferon gamma release assay (IGRA). * Positive test for drugs, cotinine (tobacco use) or alcohol use at screening or on Day -1. * Sexually active female participants of childbearing potential unwilling to use 2 protocol specified highly effective methods of contraception during treatment and for an additional 30 days after the last dose of investigational product. * Alcohol consumption from 48 hours prior to study Day 1. * Use of tobacco- or nicotine-containing products within 6 months prior to study Day 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Experiencing a Treatment-emergent Adverse Event (TEAE) | Day 1 to Day 30 (SAD/MAD) or Day 40 (food effect cohort) |
Secondary
| Measure | Time frame |
|---|---|
| SAD/MAD Only: Maximum Observed Concentration (Cmax) of AMG 378 | Day 1 to Day 30 |
| SAD/MAD Only: Time of Cmax (Tmax) of AMG 378 | Day 1 to Day 30 |
| SAD/MAD Only: Area Under the Concentration Time Curve (AUC) of AMG 378 | Day 1 to Day 30 |
| Food Effect Cohort Only: AUC of AMG 378 in the Fed Versus Fasted State | Day 1 to Day 14 |
| Food Effect Cohort Only: Cmax of AMG 378 in the Fed Versus Fasted State | Day 1 to Day 14 |
Countries
United States
Contacts
STUDY_DIRECTORMD
Amgen
Outcome results
None listed