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Completed

NCT Number: NCT02698267

Effect of Itraconazole on the Pharmacokinetics of BIIB074

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]).

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Key information

Conditions

Neuropathic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Leeds, LS2 9LH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BIIB074

Drug

Administered as specified in the treatment arm

Other names: CNV1014802

Itraconazole

Drug

200 mg twice daily [BID] on Day 8 and once daily (QD) from Day 9 to Day 15 inclusive

Other names: Sporanox, Onmel

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 3, 2016
Registry last updated
Jun 9, 2016

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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