None listed
Conditions
Brief summary
This is an open-label, single-dose, randomized, two-period, crossover study to evaluate absolute bioavailability of Brincidofovir (BCV) after administration of either: PART A (Non-Japanese) : a single, 200 mg dose of BCV suspension formulation compared to a single, 20 mg dose of BCV IV formulation. PART B: (Japanese) a single 100 mg dose of BCV suspension formulation compared to a single 10 mg dose of BCV IV formulation. A screening evaluation will be performed no more than 28 days prior to the first BCV dose (Period 1 Day 1) to identify subjects who are eligible to participate in the study. Eligible subjects will be randomized in a 1:1 ratio. In each period, BCV will be administered on Day 1. Subjects will be admitted to the clinic on Day -1, the day prior to dosing. Subjects will remain in the clinic until the morning of Day 3. A follow visit will occur following the last visit.
Interventions
This is an open-label, single-dose, randomized, two-period, crossover study to evaluate absolute bioavailability of Brincidofovir (BCV) after administration of either:
PART A (Non-Japanese) : a single, 200 mg dose of BCV suspension formulation (20 mls to be drunk) compared to a single, 20 mg dose of BCV IV formulation.
PART B: (Japanese) a single 100 mg dose of BCV suspension formulation (10 mls to be drunk) compared to a single 10 mg dose of BCV IV formulation.
All doses will be administered w
This is an open-label, single-dose, randomized, two-period, crossover study to evaluate absolute bioavailability of Brincidofovir (BCV) after administration of either: PART A (Non-Japanese) : a single, 200 mg dose of BCV suspension formulation (20 mls to be drunk) compared to a single, 20 mg dose of BCV IV formulation. PART B: (Japanese) a single 100 mg dose of BCV suspension formulation (10 mls to be drunk) compared to a single 10 mg dose of BCV IV formulation. All doses will be administered while resident in a phase 1 unit. Volunteers will need to stay 2 nights in the unit for each dose. A wash out of at least 21 days will occur between the two treatments.
Sponsors
Chimerix Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female between 18 to 70 years of age. 2. Born in Japan, have both parents and grandparents of Japanese origin, and lived for < 10 years outside of Japan (Part B only). 3. Non-Japanese (Part A only) 4. Female must be of non-childbearing potential, i.e., postmenopausal woman or a premenopausal woman documented as surgically sterile following either a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, tubal ligation or placement of bilateral fallopian tube occlusion or with medically documented ovarian failure. 5. . Males must be surgically-sterilized or agree to use two contraception methods during heterosexual intercourse with a female partner capable of becoming pregnant. 6.Willing and able to provide written informed consent.
Exclusion criteria
. Have a positive pregnancy test at screening or Day -1. 2. Have received any investigational drug,or device within 30 days prior to study start 3. Have received BCV in a previous clinical trial. 4. Have a positive test result at the screening consistent infection with HBV, HCV, or HIV. 5. Have a positive test for drugs of abuse, cotinine, and/or alcohol . 6. History of tobacco/nicotine use (Part A only). [Note: Former tobacco/nicotine users are eligible, provided the subject has not used a tobacco- or nicotine-containing product for a minimum of 6 months prior to Period 1 Day 1.] 7. Have any serious or active medical or psychiatric illness, 8. Have a history of a gastrointestinal condition or disorder 9. Have a history or symptoms of cardiovascular disease, 10. Have a history of haematological disorders such as a bleeding disorder. 11. Have a history of chronic liver disease or hepatic impairment, 12. History of Gilbert’s syndrome or a total bilirubin greater than the upper limit of the normal reference range 13.Have symptoms of infection (such as those experienced with a cold or flu,) 14. Have a history of difficulty with blood donation, including vasovagal syncope (fainting), 15. Have a clinically significant abnormal haemoglobin. 16. Have donated blood or had clinically significant blood loss within 30 days prior to study start 17. Have received any medication or herbal product known to induce or inhibit hepatic metabolizing enzymes 18. Have received any prescription medication within 14 days prior to Day 1, 19. Have received any non-prescription medication within 3 days prior to Day 1, 20. Have a history of clinically relevant drug or alcohol dependence within the past 2 years 21. Have consumed fruit juice within 3 days prior to Period 1 Day 1, 22. Any condition or set of circumstances that, in the judgment of the investigator, could interfere with the subject’s ability to comply with completion of the study.
Outcome results
None listed