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Completed

NCT Number: NCT06004947

A Study in Healthy Volunteers to Evaluate the Drug-Drug Interaction Potential of CCX168 With Concomitant Medications

The primary objective of this study will be to evaluate the drug-drug interaction potential of CCX168 with concomitant medications, as either a perpetrator or a victim, following oral administration of CCX168 to healthy participants.

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Key information

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 18-55 years inclusive, who are in generally good health as judged by the Investigator, 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 electrocardiogram, 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

  • Pregnant or breastfeeding;
  • 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; herbal supplements must be stopped 7 days prior to check-in;
  • For at least 14 days prior to check-in and throughout the blood sample collection period, participants will not be allowed to eat any food or drink any beverage containing alcohol, grapefruit or grapefruit juice, apple or orange juice, vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, mustard greens) and charbroiled meats; strenuous exercise must be stopped 4 days prior to check-in;
  • History within the three months prior to check-in of use of tobacco and/or nicotine containing products;
  • History within one year prior to check-in of illicit drug use;
  • History of alcohol abuse at any time in the past;
  • Has a history or presence of any form of cancer within the 5 years prior to check-in, with the exception of excised basal cell or squamous cell carcinoma of the skin, or cervical carcinoma in situ or breast carcinoma in situ that has been excised or resected completely and is without evidence of local recurrence or metastasis;
  • History or presence of unexplained syncope or family history of sudden death, or 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 dosing;
  • Participant's hemoglobin less than 11.5 g/dL for women or less than 13.0 g/dL for men, at screening or check-in, confirmed by a repeat measurement;
  • Participated in any clinical study of an investigational product within 30 days prior to dosing or within 5 half-lives after dosing;
  • Participant has any evidence of hepatic disease; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, or bilirubin greater than 1.5 times the upper limit of normal at screening or check-in;
  • Participant's white blood cell count is below the lower limit of normal at screening or check-in, confirmed by a repeat measurement;
  • Participant has any evidence of renal impairment; serum creatinine greater than 1.5 times the upper limit of normal at screening or check-in;
  • Participant's urine tested positive at screening and/or check-in for any of the following: opioids, amphetamines and methamphetamines, cannabinoids, benzodiazepines, barbiturates, cocaine, cotinine, methylenedioxymethamphetamine (MDMA or "ecstasy"), methadone, phencyclidine, tri-cyclic antidepressants, or alcohol (Breathalyzer test allowed for alcohol).
  • Participant is known as a CYP2C9 poor metabolizer.

Treatment and study plan

CCX168

Drug

Administered orally.

midazolam

Drug

Administered orally.

Celecoxib

Drug

Administered orally.

Itraconazole

Drug

Administered orally.

rifampicin

Drug

Administered orally.

Primary outcomes

  1. Cohort A: Maximum Plasma Concentration (Cmax) of Midazolam

    Time frame: Up to Day 13

  2. Cohort A: Cmax of Celecoxib

    Time frame: Up to Day 13

  3. Cohort A: Time of Cmax (Tmax) of Midazolam

    Time frame: Up to Day 13

  4. Cohort A: Tmax of Celecoxib

    Time frame: Up to Day 13

  5. Cohort A: Area under the plasma concentration-time curve (AUC) from Time 0 to infinity of Midazolam

    Time frame: Up to Day 13

  6. Cohort A: AUC from Time 0 to infinity of Celecoxib

    Time frame: Up to Day 13

  7. Cohort A: Apparent Terminal Half Life of Midazolam

    Time frame: Up to Day 13

  8. Cohort A: Apparent Terminal Half Life of Celecoxib

    Time frame: Up to Day 13

  9. Cohort A: Cmax of CCX168

    Time frame: Day 15 up to Day 19

  10. Cohort A: Tmax of CCX168

    Time frame: Day 15 up to Day 19

  11. Cohort A: AUC Over the Dosing Interval of CCX168

    Time frame: Day 15 up to Day 19

  12. Cohort B: Cmax of CCX168

    Time frame: Up to Day 14

  13. Cohort B: Tmax of CCX168

    Time frame: Up to Day 14

  14. Cohort B: AUC from Time 0 to infinity of CCX168

    Time frame: Up to Day 14

  15. Cohort B: Apparent Terminal Half Life of CCX168

    Time frame: Up to Day 14

Secondary outcomes

  1. Number of Participants Experiencing Adverse Events (AEs)

    Time frame: Up to Day 29

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

    Time frame: Up to Day 19

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

    Time frame: Up to Day 19

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

An Open-Label, Phase 1 Study in Healthy Volunteers to Evaluate the Drug-Drug Interaction Potential of CCX168 With Concomitant Medications

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 22, 2023
Registry last updated
Aug 22, 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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