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Trial record 27 of 205 for:    SPORANOX I.V. OR ITRACONAZOLE OR ONMEL OR SPORANOX-PULSE OR Sporanos OR R 51,211 OR SPORANOX

Phase 1 Study to Investigate Effect of Rifampin and Itraconazole on the Pharmacokinetics of BGB-3111 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT03301181
Recruitment Status : Completed
First Posted : October 4, 2017
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
BeiGene

Brief Summary:
Phase 1 study in healthy subjects to determine the effect of rifampin (Part A) or itraconazole (Part B) on the pharmacokinetics of BGB-3111

Condition or disease Intervention/treatment Phase
Healthy Volunteers: Asian, Non-Asian Drug: BGB-3111 (Arm A) Drug: Rifampin Drug: BGB-3111 (Arm B) Drug: Itraconazole Phase 1

Detailed Description:
This is a Phase 1 open-label, parallel-group study in healthy subjects. Subjects in Part A will receive a single dose of BGB-3111 before and during consecutive daily doses of strong cytochrome P450 CYP3A inducer, rifampin, to investigate its effect on the pharmacokinetics of BGB-3111. Following an interim data analysis, subjects in Part B will receive a single dose of BGB-3111 before and during consecutive daily doses of strong CYP3A inhibitor, itraconazole, to investigate its effect on the pharmacokinetics of BGB-3111.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1, Open-label, Parallel-group, Fixed-sequence Study to Investigate the Effect of the CYP3A Inducer Rifampin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of BGB-3111 in Healthy Subjects
Actual Study Start Date : September 18, 2017
Actual Primary Completion Date : November 7, 2017
Actual Study Completion Date : November 13, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A
Approximately 20 subjects to receive BGB-3111 and rifampin
Drug: BGB-3111 (Arm A)
320 mg BGB-3111 single oral dose

Drug: Rifampin
600 mg rifampin once daily
Other Name: Rifadin, Rimactane

Experimental: Arm B
Approximately 20 subjects to receive BGB-3111 and itraconazole
Drug: BGB-3111 (Arm B)
Up to 80 mg BGB-3111 single oral dose

Drug: Itraconazole
200 mg itraconazole once daily
Other Name: Sporanox, Orungal




Primary Outcome Measures :
  1. Plasma concentration of BGB-3111 and rifampin to evaluate protocol specified PK parameters [ Time Frame: Part A: Days 1 and 10 ]
  2. Plasma concentration of BGB-3111 and itraconazole to evaluate protocol specified PK parameters [ Time Frame: Part B: Days 1 and 6 ]

Secondary Outcome Measures :
  1. Safety as assessed by adverse events [ Time Frame: Part A: up to 19 days: Part B: up to 14 days ]
  2. Safety as assessed by electrocardiogram (ECG) measurements [ Time Frame: Part A: Days 1 and 10, from screening to end of study visit; up to Day 19; Part B: Days 1 and 6, from screening to end of study visit; up to Day 14 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Body mass index (BMI)18 - 32 kg/m2, inclusive.
  2. Subjects of Asian (first- or second-generation) and non-Asian descent.
  3. In good general health as assessed by the Investigator.
  4. Females must be nonpregnant and nonlactating, and females of childbearing potential will agree to use required contraception.
  5. Males without a vasectomy will agree to use required barrier contraception, and will agree to not donate sperm from the time of the first dose of BGB-3111 until ≥90 days after the last dose of BGB-3111.Able to comprehend and willing to sign consent.

Exclusion Criteria:

  1. Subjects with a clinically relevant history or presence of any clinically significant disease.
  2. Evidence of bacterial, viral, fungal, parasitic infections within 4 weeks prior to the first dose of study drug.
  3. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance.
  4. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs.
  5. History of alcoholism or drug/chemical abuse within prior year.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03301181


Locations
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United States, California
West Coast Clinical Trials (WCCT)
Cypress, California, United States, 90630
Sponsors and Collaborators
BeiGene

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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03301181     History of Changes
Other Study ID Numbers: BGB-3111-104
First Posted: October 4, 2017    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Itraconazole
Hydroxyitraconazole
Rifampin
Zanubrutinib
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers
Antineoplastic Agents
Protein Kinase Inhibitors