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

Double-Blind, Randomised, Placebo-Controlled, Parallel Group Study to Evaluate the Interaction Between a Drug and CNV1014802 in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: CNV1014802

Detailed Description

This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been acquired by Biogen.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active
• Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period
• Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than hormone replacement therapy [HRT]/hormonal contraception not containing ethinyl estradiol) or herbal remedies in the 14 days before IMP administration
• Significant medical history of fainting or vasovagal attacks
• History of uncontrolled or poorly controlled hypertension
• Semi-supine systolic BP <90 mmHg or >140 mmHg, or diastolic BP >100 mmHg after 3 assessments
• QTcB or QTcF of >450 msec in male subjects or >470 msec in females
• Presence or history of any clinically significant abnormality in vital signs or ECG
• Presence of any medical condition, which in the opinion of the investigator may interfere with the study procedures or compromise subject safety
• Medical history of clinically significant depression
• History of suicide attempt within 6 months prior to screening
• History of acute porphyria
• History of cardiac conduction disorders with the exception of 1st degree heart block
• Mentally or legally incapacitated
• Unwillingness or inability to follow the procedures outlined in the protocol, or to comply with study restrictions on smoking, concomitant medications and diet
• Failure to satisfy the investigator of fitness to participate for any other reason

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Other drug; Other drug BID	Drug: CNV1014802
Experimental: placebo; Placebo to match BID	Drug: CNV1014802

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
CNV1014802 Tmax	days 1-28
CNV1014802 Ctrough	days 1-28

Collaborators and Investigators

• Sponsor: Biogen

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2015
• Primary Completion (Actual): August 16, 2016
• Study Completion (Actual): August 26, 2016

Study Registration Dates

• First Submitted: September 7, 2015
• First Submitted That Met QC Criteria: September 15, 2015
• First Posted (Estimate): September 16, 2015

Study Record Updates

• Last Update Posted (Actual): October 16, 2017
• Last Update Submitted That Met QC Criteria: October 12, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: volunteer drug interaction study
• Other Study ID Numbers: 1014802/102; 2015-001926-41 (EudraCT Number)