ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Itraconazole on the Pharmacokinetics of BIIB074

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02698267
Recruitment Status : Completed
First Posted : March 3, 2016
Last Update Posted : June 9, 2016
Sponsor:
Information provided by (Responsible Party):
Biogen

Brief Summary:
The primary objective of the study is to assess the effect of cytochrome P450 (CYP) 3A4 inhibition on the pharmacokinetics (PK) of BIIB074. The secondary objectives of this study are to assess the safety and tolerability of BIIB074 when co-administered with a strong CYP3A4 inhibitor and to assess the effect of CYP3A4 inhibition on the PK of 3 metabolites of BIIB074 (CNV3000497 [M13], CNV2283325 [M14], and CNV2288584 [M16]).

Condition or disease Intervention/treatment Phase
Neuropathic Pain Drug: BIIB074 Drug: Itraconazole Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Fixed-sequence, Phase 1 Study of the Effect of CYP3A4 Inhibition by Itraconazole on the Pharmacokinetics of BIIB074 in Healthy Subjects
Study Start Date : February 2016
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BIIB074
Administered orally on Day 1 and Day 11
Drug: BIIB074
Administered as specified in the treatment arm
Other Name: CNV1014802

Drug: Itraconazole
200 mg twice daily [BID] on Day 8 and once daily (QD) from Day 9 to Day 15 inclusive
Other Name: Sporanox, Onmel




Primary Outcome Measures :
  1. Maximum observed concentration (Cmax) of BIIB074 [ Time Frame: Prior to dosing up to 96 hours post dose ]
  2. Exposure of BIIB074 as measured by area under the concentration-time curve from time zero to infinity (AUCinf) [ Time Frame: Prior to dosing up to 96 hours post dose ]

Secondary Outcome Measures :
  1. Terminal elimination half-life (t1/2) of BIIB074 [ Time Frame: 96 hours post dose ]
  2. Apparent total body clearance (CL/F) of BIIB074 [ Time Frame: 96 hours post dose ]
  3. Apparent volume of distribution (Vd/F) of BIIB074 [ Time Frame: 96 hours post dose ]
  4. Area under the concentration-time curve from time zero to time of the last measurable drug concentration (AUC0-t) of BIIB074 [ Time Frame: Prior to dosing up to 96 hours post dose ]
  5. Time that the maximum observed concentration occurs (Tmax) of BIIB074 [ Time Frame: Prior to dosing up to 96 hours post dose ]
  6. Number of participants experiencing adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to 25 days ]
  7. Number of participants with clinically significant vital sign abnormalities [ Time Frame: Up to 25 days ]
  8. Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities [ Time Frame: Up to 25 days ]
  9. Number of participants with clinically significant laboratory assessment abnormalities [ Time Frame: Up to 25 days ]
  10. Effect of CYP3A4 inhibition on the Cmax of 3 metabolites of BIIB074 [ Time Frame: Prior to dosing up to 96 hours post dose ]
  11. Effect of CYP3A4 inhibition on the AUCinf of 3 metabolites of BIIB074 [ Time Frame: Prior to dosing up to 96 hours post dose ]
  12. Effect of CYP3A4 inhibition on the AUC0-t of CNV3000497 (M13) [ Time Frame: Prior to dosing up to 96 hours post dose ]
  13. Effect of CYP3A4 inhibition on the AUC0-t of CNV2283325 (M14) [ Time Frame: Prior to dosing up to 96 hours post dose ]
  14. Effect of CYP3A4 inhibition on the AUC0-t of CNV2288584 (M16) [ Time Frame: Prior to dosing up to 96 hours post dose ]
  15. Effect of CYP3A4 inhibition on the Tmax of CNV3000497 (M13) [ Time Frame: Prior to dosing up to 96 hours post dose ]
  16. Effect of CYP3A4 inhibition on the Tmax of CNV2283325 (M14) [ Time Frame: Prior to dosing up to 96 hours post dose ]
  17. Effect of CYP3A4 inhibition on the Tmax of CNV2288584 (M16) [ Time Frame: Prior to dosing up to 96 hours post dose ]
  18. Effect of CYP3A4 inhibition on the t1/2 of CNV3000497 (M13) [ Time Frame: Prior to dosing up to 96 hours post dose ]
  19. Effect of CYP3A4 inhibition on the t1/2 of CNV2283325 (M14) [ Time Frame: Prior to dosing up to 96 hours post dose ]
  20. Effect of CYP3A4 inhibition on the t1/2 of CNV2288584 (M16) [ Time Frame: Prior to dosing up to 96 hours post dose ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  • Body mass index of 18 to 29 kg/m2, inclusive, with body weight ≥50 kg for males and ≥45 kg for females.
  • Male or postmenopausal or surgically sterile females.
  • Must be in good health as determined by the Investigator (or designee), based on medical history and screening evaluations.

Key Exclusion Criteria:

  • Females of childbearing potential.
  • Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrollment.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.


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): NCT02698267


Locations
United Kingdom
Research Site
Leeds, United Kingdom, LS2 9LH
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02698267     History of Changes
Other Study ID Numbers: 802HV104
2015-005096-25 ( EudraCT Number )
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: June 9, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Itraconazole
Hydroxyitraconazole
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