An Open-Label, Phase 1 Study in Healthy Volunteers to Evaluate the Pharmacokinetic Food Effect and Cardiac Safety of CCX168
Overview
- Phase
- Phase 1
- Intervention
- CCX168
- Conditions
- Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis
- Sponsor
- Amgen
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Area Under the Plasma Concentration-time Curve (AUC) of CCX168 From Time 0 to Time t (AUC0-t)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The primary objective of this clinical trial is to evaluate the effect of a high-fat, high-calorie meal on the pharmacokinetic (PK) profile of CCX168, following oral administration of a single dose of 30 mg CCX168 to healthy volunteers.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female participants, aged 18-55 years inclusive, who are in generally good health, whose body mass index is 19.0 to 32.0 kg/m\^2 inclusive;
- •Willing and able to give written Informed Consent and to comply with the requirements of the study protocol;
- •Negative result of the human immunodeficiency virus screen, the hepatitis B screen, and the hepatitis C screen;
- •Judged to be healthy by the Investigator, based on medical history, physical examination (including ECG, and clinical laboratory assessments. Participants with clinical laboratory values that are outside of normal limits and/or with other abnormal clinical findings that are judged by the Investigator not to be of clinical significance may be entered into the study;
- •Female participants of childbearing potential, or male participants with partners of childbearing potential may participate if adequate contraception is used during, and for at least 90 days after, any administration of study medication.
Exclusion Criteria
- •Women who are pregnant, lactating, or have a positive serum pregnancy test at screening or check-in (Day -2);
- •Myocardial infarction or active ischemic heart disease within 12 months before screening;
- •Significant abnormal ECG: Pacemaker, any conduction abnormality associated with a QRS ≥120 msec, poorly-defined or abnormal T wave morphology precluding end of T measurement, abnormal rhythm for age, evidence of previous myocardial infarction (Q waves, S-T segment changes), sinus pauses \> 2.5 seconds, ventricular couplets, triplets or other arrhythmia, symptomatic or asymptomatic;
- •Has any of the following abnormalities:
- •Heart rate \<40 or \>100 bpm
- •PR interval \<110 or ≥220 msec
- •QRS duration ≥120 msec
- •QTcF interval \<350 or \>450 msec;
- •History of additional significant risk factors for torsade de pointes, including heart failure, hypokalemia, hypocalcemia, hypomagnesemia, family history of long QT syndrome;
- •Used a prescription and/or over-the-counter medication, with the exception of ibuprofen, hormonal contraceptives, and multi-vitamins, within 14 days prior to check-in;
Arms & Interventions
Cohort 1: Sequence ABCD
Participants assigned to sequence ABCD will receive the following treatments: Period 1: Single dose of 30 mg CCX168 after a high-fat, high-calorie meal (Treatment A). Period 2: After a washout period of ≥ 10 days, single dose of 30 mg CCX168 in the fasted state (Treatment B). Period 3: After a washout period of ≥ 10 days, single dose of 3 mg CCX168 in the fasted state (Treatment C). Period 4: 24 hours after the 3 mg CCX168 dose in Period 3, single dose of 100 mg CCX168 on Day 1, and then 100 mg CCX168 twice daily from Day 2 through Day 6. On Day 7, only a morning dose of 100 mg CCX168 (Treatment D).
Intervention: CCX168
Cohort 2: Sequence BACD
Participants assigned to sequence BACD will receive the following treatments: Period 1: Single dose of 30 mg CCX168 in the fasted state (Treatment B). Period 2: After a washout period of ≥ 10 days, single dose of 30 mg CCX168 after a high-fat, high-calorie meal (Treatment A). Period 3: After a washout period of ≥ 10 days, single dose of 3 mg CCX168 in the fasted state (Treatment C). Period 4: 24 hours after the 3 mg CCX168 dose in Period 3, single dose of 100 mg CCX168 on Day 1, and then 100 mg CCX168 twice daily from Day 2 through Day 6. On Day 7, only a morning dose of 100 mg CCX168 (Treatment D).
Intervention: CCX168
Outcomes
Primary Outcomes
Area Under the Plasma Concentration-time Curve (AUC) of CCX168 From Time 0 to Time t (AUC0-t)
Time Frame: Up to 35 days
AUC of CCX168 From Time 0 to Infinity (AUC0-inf)
Time Frame: Up to 35 days
Maximum Plasma Concentration (Cmax) of CCX168
Time Frame: Up to 35 days
Time of Cmax (Tmax) of CCX168
Time Frame: Up to 35 days
Secondary Outcomes
- Number of Participants Experiencing Adverse Events (AEs)(Up to 35 days)
- Number of Participants Experiencing Clinically Significant Changes in Laboratory Parameters(Up to 35 days)
- Number of Participants Experiencing Clinically Significant Changes in Electrocardiogram (ECG) Parameters(Up to 35 days)
- Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters(Up to 35 days)