Healthy
Conditions
Keywords
volunteer drug interaction study
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.
Detailed description
This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been acquired by Biogen.
Interventions
DRUGCNV1014802
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety laboratory tests | Days 16-21 |
| Blood pressure | Days16-21 |
| ECG | Days 16-21 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| CNV1014802 Ctrough | days 1-28 |
| CNV1014802 Tmax | days 1-28 |
Countries
United Kingdom
Outcome results
None listed