Effect of Itraconazole on the Pharmacokinetics of BIIB074

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Biogen

Status and phase

Completed
Phase 1

Conditions

Neuropathic Pain

Treatments

Drug: BIIB074
Drug: Itraconazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT02698267
2015-005096-25 (EudraCT Number)
802HV104

Details and patient eligibility

About

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 \[M16\]).

Enrollment

16 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

16 participants in 1 patient group

BIIB074
Experimental group
Description:
Administered orally on Day 1 and Day 11
Treatment:
Drug: Itraconazole
Drug: BIIB074

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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