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Effect of Itraconazole on the Pharmacokinetics of BIIB074

Primary Purpose

Neuropathic Pain

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

BIIB074

Itraconazole

About this trial

This is an interventional treatment trial for Neuropathic Pain

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BIIB074

Arm Description

Administered orally on Day 1 and Day 11

Outcomes

Primary Outcome Measures

Maximum observed concentration (Cmax) of BIIB074

Exposure of BIIB074 as measured by area under the concentration-time curve from time zero to infinity (AUCinf)

Secondary Outcome Measures

Terminal elimination half-life (t1/2) of BIIB074

Apparent total body clearance (CL/F) of BIIB074

Apparent volume of distribution (Vd/F) of BIIB074

Area under the concentration-time curve from time zero to time of the last measurable drug concentration (AUC0-t) of BIIB074

Time that the maximum observed concentration occurs (Tmax) of BIIB074

Number of participants experiencing adverse events (AEs) and serious adverse events (SAEs)

Number of participants with clinically significant vital sign abnormalities

Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities

Number of participants with clinically significant laboratory assessment abnormalities

Effect of CYP3A4 inhibition on the Cmax of 3 metabolites of BIIB074

Effect of CYP3A4 inhibition on the AUCinf of 3 metabolites of BIIB074

Effect of CYP3A4 inhibition on the AUC0-t of CNV3000497 (M13)

Effect of CYP3A4 inhibition on the AUC0-t of CNV2283325 (M14)

Effect of CYP3A4 inhibition on the AUC0-t of CNV2288584 (M16)

Effect of CYP3A4 inhibition on the Tmax of CNV3000497 (M13)

Effect of CYP3A4 inhibition on the Tmax of CNV2283325 (M14)

Effect of CYP3A4 inhibition on the Tmax of CNV2288584 (M16)

Effect of CYP3A4 inhibition on the t1/2 of CNV3000497 (M13)

Effect of CYP3A4 inhibition on the t1/2 of CNV2283325 (M14)

Effect of CYP3A4 inhibition on the t1/2 of CNV2288584 (M16)

Full Information

NCT ID

NCT02698267

First Posted

February 29, 2016

Last Updated

June 7, 2016

Sponsor

Biogen

1. Study Identification

Unique Protocol Identification Number

NCT02698267

Brief Title

Effect of Itraconazole on the Pharmacokinetics of BIIB074

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 Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Completed

Study Start Date

February 2016 (undefined)

Primary Completion Date

April 2016 (Actual)

Study Completion Date

April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biogen

4. Oversight

Data Monitoring Committee

5. Study Description

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]).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuropathic Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BIIB074

Arm Type

Experimental

Arm Description

Administered orally on Day 1 and Day 11

Intervention Type

Drug

Intervention Name(s)

BIIB074

Other Intervention Name(s)

CNV1014802

Intervention Description

Administered as specified in the treatment arm

Intervention Type

Drug

Intervention Name(s)

Itraconazole

Other Intervention Name(s)

Sporanox, Onmel

Intervention Description

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

Primary Outcome Measure Information:

Title

Maximum observed concentration (Cmax) of BIIB074

Time Frame

Prior to dosing up to 96 hours post dose

Title

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 Measure Information:

Title

Terminal elimination half-life (t1/2) of BIIB074

Time Frame

96 hours post dose

Title

Apparent total body clearance (CL/F) of BIIB074

Time Frame

96 hours post dose

Title

Apparent volume of distribution (Vd/F) of BIIB074

Time Frame

96 hours post dose

Title

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

Title

Time that the maximum observed concentration occurs (Tmax) of BIIB074

Time Frame

Prior to dosing up to 96 hours post dose

Title

Number of participants experiencing adverse events (AEs) and serious adverse events (SAEs)

Time Frame

Up to 25 days

Title

Number of participants with clinically significant vital sign abnormalities

Time Frame

Up to 25 days

Title

Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities

Time Frame

Up to 25 days

Title

Number of participants with clinically significant laboratory assessment abnormalities

Time Frame

Up to 25 days

Title

Effect of CYP3A4 inhibition on the Cmax of 3 metabolites of BIIB074

Time Frame

Prior to dosing up to 96 hours post dose

Title

Effect of CYP3A4 inhibition on the AUCinf of 3 metabolites of BIIB074

Time Frame

Prior to dosing up to 96 hours post dose

Title

Effect of CYP3A4 inhibition on the AUC0-t of CNV3000497 (M13)

Time Frame

Prior to dosing up to 96 hours post dose

Title

Effect of CYP3A4 inhibition on the AUC0-t of CNV2283325 (M14)

Time Frame

Prior to dosing up to 96 hours post dose

Title

Effect of CYP3A4 inhibition on the AUC0-t of CNV2288584 (M16)

Time Frame

Prior to dosing up to 96 hours post dose

Title

Effect of CYP3A4 inhibition on the Tmax of CNV3000497 (M13)

Time Frame

Prior to dosing up to 96 hours post dose

Title

Effect of CYP3A4 inhibition on the Tmax of CNV2283325 (M14)

Time Frame

Prior to dosing up to 96 hours post dose

Title

Effect of CYP3A4 inhibition on the Tmax of CNV2288584 (M16)

Time Frame

Prior to dosing up to 96 hours post dose

Title

Effect of CYP3A4 inhibition on the t1/2 of CNV3000497 (M13)

Time Frame

Prior to dosing up to 96 hours post dose

Title

Effect of CYP3A4 inhibition on the t1/2 of CNV2283325 (M14)

Time Frame

Prior to dosing up to 96 hours post dose

Title

Effect of CYP3A4 inhibition on the t1/2 of CNV2288584 (M16)

Time Frame

Prior to dosing up to 96 hours post dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Biogen

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Leeds

ZIP/Postal Code

LS2 9LH

Country

United Kingdom

12. IPD Sharing Statement

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Effect of Itraconazole on the Pharmacokinetics of BIIB074

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