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OpenTrials
Completed

NCT Number: NCT05984251

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

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.

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Key information

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit (CRU) AG

Allschwil, CH-4123, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

CCX168

Drug

Administered orally.

Placebo

Drug

Administered orally.

Primary outcomes

  1. Number of Participants Experiencing Adverse Events (AEs)

    Time frame: Up to 43 days

  2. Number of Participants Experiencing Clinically Significant Changes in Laboratory Parameters

    Time frame: Up to 29 days

  3. Number of Participants Experiencing Clinically Significant Changes in Electrocardiogram (ECG) Parameters

    Time frame: Up to 29 days

  4. Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters

    Time frame: Up to 29 days

Secondary outcomes

  1. Maximum Plasma Concentration (Cmax) of CCX168

    Time frame: Period 1: Up to Day 8; Period 2: Up to Day 15

  2. Time of Cmax of CCX168

    Time frame: Period 1: Up to Day 8; Period 2: Up to Day 15

  3. Terminal Phase Rate Constant of CCX168

    Time frame: Period 1: Up to Day 8; Period 2: Up to Day 15

  4. Apparent Terminal Half-life of CCX168

    Time frame: Period 1: Up to Day 8; Period 2: Up to Day 15

  5. Apparent Oral Clearance of CCX168

    Time frame: Period 1: Up to Day 8; Period 2: Up to Day 15

  6. Apparent Volume of Distribution of CCX168

    Time frame: Period 1: Up to Day 8; Period 2: Up to Day 15

  7. Area Under the Plasma Concentration-time Curve (AUC) of CCX168 From Time 0 to Time t

    Time frame: Period 1: Up to Day 8; Period 2: Up to Day 15

  8. AUC of CCX168 From Time 0 to Infinity

    Time frame: Period 1: Up to Day 8; Period 2: Up to Day 15

  9. AUC of CCX168 From Time 0 to 24 Hours

    Time frame: Periods 1 and 2: Up to Hour 24

  10. AUC of CCX168 From Time 0 to 12 Hours

    Time frame: Periods 1 and 2: Up to Hour 12

  11. AUC of CCX168 From Time 12 to 24 Hours

    Time frame: Periods 1 and 2: Hour 12 to Hour 24

  12. Period 2: AUC of CCX168 From Time 0 to the end of the Dosing Interval

    Time frame: Cohorts 1-3: Up to Hour 24; Cohorts 4-5: Up to Hour 12

  13. Period 2: Accumulation Ratio of CCX168

    Time frame: Up to Day 7

  14. Percent Inhibition of complement 5a receptor (C5aR)-dependent Upregulation of CD11b in Peripheral Blood Neutrophils

    Time frame: Period 1: Up to Hour 24; Period 2: Up to 12 hours after the first dose on Day 7

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CCX168 in Healthy Male and Female Subjects

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Aug 9, 2023
Registry last updated
Aug 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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