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

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

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