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

Biogen

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: CNV1014802

Study type

Interventional

Funder types

Industry

Identifiers

NCT02551497

1014802/102

2015-001926-41 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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

Enrollment

36 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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