Study to Evaluate the Interaction Between a Drug and CNV1014802 in Healthy Subjects

NCT02551497 | Completed Phase 1

• 2 other identifiers: 1014802/1022015-001926-41
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This is a double-blind, randomised, placebo-controlled 3 period study to evaluate the interaction between a drug and CNV1014802 in healthy male and female subjects. It is planned to enrol 36 subjects.

Conditions

Healthy

Keywords

volunteer drug interaction study

Outcome Measures

Primary Outcomes (7)

• AUC(0-tau) of CNV1014802 and a drug

  days 1-28

• Cmax of CNV1014802 and a drug

  5 days

• number of AEs

  Days 16 to 21

• heart rate

  Days16-21

• Blood pressure

  Days16-21

• ECG

  Days 16-21

• safety laboratory tests

  Days 16-21

Secondary Outcomes (2)

• CNV1014802 Tmax

  days 1-28

• CNV1014802 Ctrough

  days 1-28

Study Arms (2)

Other drug

EXPERIMENTAL

Other drug BID

Drug: CNV1014802

placebo

EXPERIMENTAL

Placebo to match BID

Drug: CNV1014802

Interventions

CNV1014802 DRUG

Other drug; placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males, or non-pregnant, non-lactating healthy females either of non-child bearing potential, or taking an approved method of contraception for the duration of the study
• Age 18 to 55 years of age, inclusive
• Non-smoking subjects with body weight ≥45 kg
• Body mass index (BMI) of 18 to 32 kg/m2 (inclusive)
• Must be willing and able to communicate and participate in the whole study
• Must provide written informed consent
• Must agree to use an adequate method of contraception

You may not qualify if:

• Participation in a clinical research study within the previous 3 months
• Subjects who are study site employees, or immediate family members of a study site or sponsor employee
• Subjects who have previously been enrolled in this study
• History of any drug or alcohol abuse in the past 2 years
• History of regular alcohol consumption within 6 months of the study (male subjects \>21 units per week or female subjects \>14 units per week; 1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
• Positive alcohol breath test
• Current smokers and those who have smoked within the last 6 months. A breath carbon monoxide reading of greater than 10 ppm at screening
• Females of childbearing potential who are pregnant or lactating (female subjects must have a negative urine pregnancy test at admission)
• Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
• Clinically significant abnormal biochemistry, haematology or urinalysis
• Positive drugs of abuse test result
• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
• Positive genotyping test
• History of cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease as judged by the investigator
• Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Research Site

Nottingham, United Kingdom

Location

MeSH Terms

Interventions

vixotrigine

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2015
• First Posted: September 16, 2015
• Study Start: April 30, 2015
• Primary Completion: August 16, 2016
• Study Completion: August 26, 2016
• Last Updated: October 16, 2017

Record last verified: 2017-10

Locations

GB (1)