A Study in Healthy Volunteers to Evaluate the Drug-Drug Interaction Potential of CCX168 With Concomitant Medications
An Open-Label, Phase 1 Study in Healthy Volunteers to Evaluate the Drug-Drug Interaction Potential of CCX168 With Concomitant Medications
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Locations
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Arizona
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Tempe, Arizona, United States, 85283
- Celerion
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Experimental: Cohort A
A single dose of 2 mg midazolam (a Cytochrome P450 [CYP]3A4 probe drug) and a single dose of 200 mg celecoxib (a CYP2C9 probe drug) will be given orally concurrently on Day 1 and Day 13.
On Day 3 through Day 18, CCX168 will be given orally at 30 mg twice daily (b.i.d.), and a single dose of 30 mg CCX168 will be given in the morning on Day 19.
On Day 16 through Day 19, a once daily (q.d.) dose of 200 mg itraconazole (a CYP3A4 inhibitor) will be given orally.
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Administered orally.
Administered orally.
Administered orally.
Administered orally.
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Experimental: Cohort B
A single dose of 30 mg CCX168 will be given on Day 1 and Day 14, while rifampicin (a CYP3A4 inducer) will be given at 600 mg once daily from Day 4 through Day 17.
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Administered orally.
Administered orally.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Cohort A: Maximum Plasma Concentration (Cmax) of Midazolam
Time Frame: Up to Day 13
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Up to Day 13
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Cohort A: Cmax of Celecoxib
Time Frame: Up to Day 13
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Up to Day 13
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Cohort A: Time of Cmax (Tmax) of Midazolam
Time Frame: Up to Day 13
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Up to Day 13
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Cohort A: Tmax of Celecoxib
Time Frame: Up to Day 13
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Up to Day 13
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Cohort A: Area under the plasma concentration-time curve (AUC) from Time 0 to infinity of Midazolam
Time Frame: Up to Day 13
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Up to Day 13
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Cohort A: AUC from Time 0 to infinity of Celecoxib
Time Frame: Up to Day 13
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Up to Day 13
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Cohort A: Apparent Terminal Half Life of Midazolam
Time Frame: Up to Day 13
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Up to Day 13
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Cohort A: Apparent Terminal Half Life of Celecoxib
Time Frame: Up to Day 13
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Up to Day 13
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Cohort A: Cmax of CCX168
Time Frame: Day 15 up to Day 19
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Day 15 up to Day 19
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Cohort A: Tmax of CCX168
Time Frame: Day 15 up to Day 19
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Day 15 up to Day 19
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Cohort A: AUC Over the Dosing Interval of CCX168
Time Frame: Day 15 up to Day 19
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Day 15 up to Day 19
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Cohort B: Cmax of CCX168
Time Frame: Up to Day 14
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Up to Day 14
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Cohort B: Tmax of CCX168
Time Frame: Up to Day 14
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Up to Day 14
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Cohort B: AUC from Time 0 to infinity of CCX168
Time Frame: Up to Day 14
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Up to Day 14
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Cohort B: Apparent Terminal Half Life of CCX168
Time Frame: Up to Day 14
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Up to Day 14
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Number of Participants Experiencing Adverse Events (AEs)
Time Frame: Up to Day 29
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Up to Day 29
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Number of Participants Experiencing Clinically Significant Changes in Laboratory Parameters
Time Frame: Up to Day 19
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Up to Day 19
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Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters
Time Frame: Up to Day 19
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Up to Day 19
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: MD, Amgen
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Immune System Diseases
- Autoimmune Diseases
- Skin Diseases, Vascular
- Systemic Vasculitis
- Vasculitis
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Bacterial Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Leprostatic Agents
- Hormone Antagonists
- Cytochrome P-450 Enzyme Inducers
- Antifungal Agents
- Steroid Synthesis Inhibitors
- Cyclooxygenase 2 Inhibitors
- Cytochrome P-450 CYP3A Inducers
- Antitubercular Agents
- 14-alpha Demethylase Inhibitors
- Antibiotics, Antitubercular
- Cytochrome P-450 CYP2B6 Inducers
- Cytochrome P-450 CYP2C8 Inducers
- Cytochrome P-450 CYP2C19 Inducers
- Cytochrome P-450 CYP2C9 Inducers
- Midazolam
- Celecoxib
- Rifampin
- Itraconazole
Other Study ID Numbers
Other Study ID Numbers
- CL008_168
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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