A study comparing Brincidofovir administered as an oral suspension versus Intravenous Formulation in Japanese and Non-Japanese Adult Volunteers

Phase 1

• Conditions: Viral Infection - orthopoxviruses; Viral Infection - polyomaviruses; Viral Infection - human herpesviruses (HHV); Viral Infection - human papillomaviruses (HPV),; Viral Infection - adenoviruses (AdV).; Infection - Other infectious diseases

• Registration Number: ACTRN12618002011268
• Lead Sponsor: Chimerix Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-14
• Last Update Posted: 14 January 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified