A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CCX168 in Healthy Participants

NCT ID: NCT05984251

Last Updated: 2023-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-21
• Study Completion Date: 2011-04-11

Brief Summary

The primary objective of this study will be to evaluate the safety and tolerability of single and multiple oral doses of CCX168, over a range of dose levels, in healthy male and female participants.

Conditions

Vasculitis; Systemic Lupus Erythematosus (SLE)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Cohort 1

During Period 1, participants will receive a single dose of CCX168 1 mg or placebo. During the second study period, participants will receive the same dose as during the first period but once daily (QD) for a period of 7 days continuously.

Group Type: EXPERIMENTAL

CCX168

Intervention Type: DRUG

Administered orally.

Placebo

Intervention Type: DRUG

Administered orally.

Cohort 2

During Period 1, participants will receive a single dose of CCX168 3 mg or placebo. During the second study period, participants will receive the same dose as during the first period but QD for a period of 7 days continuously.

Group Type: EXPERIMENTAL

CCX168

Intervention Type: DRUG

Administered orally.

Placebo

Intervention Type: DRUG

Administered orally.

Cohort 3

During Period 1, participants will receive a single dose of CCX168 10 mg or placebo. During the second study period, participants will receive the same dose as during the first period but QD for a period of 7 days continuously.

Group Type: EXPERIMENTAL

CCX168

Intervention Type: DRUG

Administered orally.

Placebo

Intervention Type: DRUG

Administered orally.

Cohort 4

During Period 1, participants will receive a single dose of CCX168 30 mg or placebo. During the second study period, participants will receive the same dose as during the first period or placebo twice daily (BID) for a period of 7 days continuously.

Group Type: EXPERIMENTAL

CCX168

Intervention Type: DRUG

Administered orally.

Placebo

Intervention Type: DRUG

Administered orally.

Cohort 5

During Period 1, participants will receive a single dose of CCX168 100 mg or placebo. During the second study period, participants will receive the same dose as during the first period or placebo BID for a period of 7 days continuously.

Group Type: EXPERIMENTAL

CCX168

Intervention Type: DRUG

Administered orally.

Placebo

Intervention Type: DRUG

Administered orally.

Interventions

CCX168

Administered orally.

Intervention Type: DRUG

Placebo

Administered orally.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female participants, aged 19-45 years inclusive, who are in generally good health, whose body mass index is 19 to 29 kg/m^2;
• 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, and
• Female participants of childbearing potential, and male participants with partners of childbearing potential, may participate if adequate contraception is used during, and for at least the four weeks after, any administration of study medication.

Exclusion Criteria

• Women who are pregnant, breastfeeding, or have a positive serum pregnancy test at Screening and/or on Study Day -1;
• Expected requirement for use of any medication (with the exception of continuing use by female participants of hormonal contraceptives in accordance with a regimen that has been stable for at least the three months prior to Screening) during the study period;
• History within the three months prior to study entry of use of tobacco and/or nicotine containing products;
• History within one year prior to study entry of illicit drug use;
• History of alcohol abuse at any time in the past;
• History of any form of cancer;
• Consumed alcoholic beverages, or any food or drink containing grapefruit or grapefruit juice within 24 hours of screening;
• History or presence of any medical condition or disease which, in the opinion of the Investigator, may place the participant at unacceptable risk for study participation;
• Donated or lost more than 350 mL of blood or blood products within 56 days prior to Screening, or donated plasma within 7 days of randomization;
• Participant's hemoglobin less than 12 g/dL (or less than 7.45 mmol/L);
• Participated in any clinical study of an investigational product within 30 days prior to randomization;
• Participant has any evidence of hepatic disease; aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transpeptidase, alkaline phosphatase, or bilirubin > 1.5 x the upper limit of normal;
• Participant has any evidence of renal impairment; serum creatinine > 1.5 x upper limit of normal, and
• Participant's urine tested positive at Screening and/or on Study Day -1 for any of the following: opioids, amphetamines, cannabinoids, benzodiazepines, barbiturates, cocaine, cotinine, or alcohol (Breathalyzer test allowed for alcohol).

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Covance Clinical Research Unit (CRU) AG

Allschwil, , Switzerland

Countries

Switzerland

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

CL001_168

Identifier Type: -

Identifier Source: org_study_id