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

Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06004947
• Other study ID #: CL008_168
• Status: Completed
• Phase: Phase 1
• Start date: January 14, 2016
• Est. completion date: June 10, 2016

Study information

• Verified date: August 2023
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 10, 2016
• Est. primary completion date: March 15, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis
• Vasculitis

Intervention

Drug:
• CCX168
Administered orally.
• Midazolam
Administered orally.
• Celecoxib
Administered orally.
• Itraconazole
Administered orally.
• Rifampicin
Administered orally.

Locations

Country	Name	City	State
United States	Celerion	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cohort A: Maximum Plasma Concentration (Cmax) of Midazolam		Up to Day 13
Primary	Cohort A: Cmax of Celecoxib		Up to Day 13
Primary	Cohort A: Time of Cmax (Tmax) of Midazolam		Up to Day 13
Primary	Cohort A: Tmax of Celecoxib		Up to Day 13
Primary	Cohort A: Area under the plasma concentration-time curve (AUC) from Time 0 to infinity of Midazolam		Up to Day 13
Primary	Cohort A: AUC from Time 0 to infinity of Celecoxib		Up to Day 13
Primary	Cohort A: Apparent Terminal Half Life of Midazolam		Up to Day 13
Primary	Cohort A: Apparent Terminal Half Life of Celecoxib		Up to Day 13
Primary	Cohort A: Cmax of CCX168		Day 15 up to Day 19
Primary	Cohort A: Tmax of CCX168		Day 15 up to Day 19
Primary	Cohort A: AUC Over the Dosing Interval of CCX168		Day 15 up to Day 19
Primary	Cohort B: Cmax of CCX168		Up to Day 14
Primary	Cohort B: Tmax of CCX168		Up to Day 14
Primary	Cohort B: AUC from Time 0 to infinity of CCX168		Up to Day 14
Primary	Cohort B: Apparent Terminal Half Life of CCX168		Up to Day 14
Secondary	Number of Participants Experiencing Adverse Events (AEs)		Up to Day 29
Secondary	Number of Participants Experiencing Clinically Significant Changes in Laboratory Parameters		Up to Day 19
Secondary	Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters		Up to Day 19

External Links

•   AmgenTrials clinical trials website