Effect of Itraconazole on the Pharmacokinetics of BIIB074

Neuropathic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02698267
• Other study ID #: 802HV104
• Secondary ID: 2015-005096-25
• Status: Completed
• Phase: Phase 1
• First received: February 29, 2016
• Last updated: June 7, 2016
• Start date: February 2016
• Est. completion date: April 2016

Study information

• Verified date: June 2016
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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]).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Drug:
• BIIB074
Administered as specified in the treatment arm
• Itraconazole
200 mg twice daily [BID] on Day 8 and once daily (QD) from Day 9 to Day 15 inclusive

Locations

Country	Name	City	State
United Kingdom	Research Site	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed concentration (Cmax) of BIIB074		Prior to dosing up to 96 hours post dose	No
Primary	Exposure of BIIB074 as measured by area under the concentration-time curve from time zero to infinity (AUCinf)		Prior to dosing up to 96 hours post dose	No
Secondary	Terminal elimination half-life (t1/2) of BIIB074		96 hours post dose	No
Secondary	Apparent total body clearance (CL/F) of BIIB074		96 hours post dose	No
Secondary	Apparent volume of distribution (Vd/F) of BIIB074		96 hours post dose	No
Secondary	Area under the concentration-time curve from time zero to time of the last measurable drug concentration (AUC0-t) of BIIB074		Prior to dosing up to 96 hours post dose	No
Secondary	Time that the maximum observed concentration occurs (Tmax) of BIIB074		Prior to dosing up to 96 hours post dose	No
Secondary	Number of participants experiencing adverse events (AEs) and serious adverse events (SAEs)		Up to 25 days	Yes
Secondary	Number of participants with clinically significant vital sign abnormalities		Up to 25 days	Yes
Secondary	Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities		Up to 25 days	Yes
Secondary	Number of participants with clinically significant laboratory assessment abnormalities		Up to 25 days	Yes
Secondary	Effect of CYP3A4 inhibition on the Cmax of 3 metabolites of BIIB074		Prior to dosing up to 96 hours post dose	No
Secondary	Effect of CYP3A4 inhibition on the AUCinf of 3 metabolites of BIIB074		Prior to dosing up to 96 hours post dose	No
Secondary	Effect of CYP3A4 inhibition on the AUC0-t of CNV3000497 (M13)		Prior to dosing up to 96 hours post dose	No
Secondary	Effect of CYP3A4 inhibition on the AUC0-t of CNV2283325 (M14)		Prior to dosing up to 96 hours post dose	No
Secondary	Effect of CYP3A4 inhibition on the AUC0-t of CNV2288584 (M16)		Prior to dosing up to 96 hours post dose	No
Secondary	Effect of CYP3A4 inhibition on the Tmax of CNV3000497 (M13)		Prior to dosing up to 96 hours post dose	No
Secondary	Effect of CYP3A4 inhibition on the Tmax of CNV2283325 (M14)		Prior to dosing up to 96 hours post dose	No
Secondary	Effect of CYP3A4 inhibition on the Tmax of CNV2288584 (M16)		Prior to dosing up to 96 hours post dose	No
Secondary	Effect of CYP3A4 inhibition on the t1/2 of CNV3000497 (M13)		Prior to dosing up to 96 hours post dose	No
Secondary	Effect of CYP3A4 inhibition on the t1/2 of CNV2283325 (M14)		Prior to dosing up to 96 hours post dose	No
Secondary	Effect of CYP3A4 inhibition on the t1/2 of CNV2288584 (M16)		Prior to dosing up to 96 hours post dose	No