A study to compare the capsule formulation of BIT225 to the original powder formulation in healthy participants.
- Conditions
- Hepatits C VirusInfection - Other infectious diseases
- Registration Number
- ACTRN12613000400763
- Lead Sponsor
- Biotron Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 14
1. Be male or female (of non-child bearing potential), aged between 18 and 49 years (inclusive).
2. Healthy participants – defined as participants who are free from clinically significant illness or disease as determined by their medical history, physical examination, 12- lead ECG (QTc less than 450 ms) and clinical laboratory determinations.
3. Normotensive (systolic BP less than 140 mm Hg and diastolic BP less than 90 mm Hg).
4. Body Mass Index (BMI) btween 19 and 29 kg/m2.
5. Weight between 55 kg and 110kg.
6. Participants who smoke less than one cigarette or tobacco form (including cigars) per month in the last 12 months.
7. Adequate venous access in the left or right arm to allow collection of a number of blood samples.
8. Fluent in the English language.
9. Provide written informed consent to participate in the study and be willing to comply with the study procedures.
10. No abnormal finding of clinical relevance at the screening evaluation.
11. Agree to use a combination of two approved methods of contraception, from screening and until 30 days after administration of the study drug.
12. Females must have a negative pregnancy test at Screening (baseline) and Day -1.
1. Currently taking or have taken antiretroviral therapy in the last 30 days.
2. Any condition that would interfere with drug absorption (e.g. chronic diarrhoea).
3. A history of pancreatitis or hepatitis within the previous 3 years.
4. Abnormal laboratory test results, deemed clinically significant by the Medical Officer (Principal Investigator or medically qualified nominee), within 21 days before enrolment, including anaemia (haemoglobin less than 11.0 g/dl for men and 10.0 g/dl for women), neutropenia, thrombocytopenia and elevated liver function test results more than two times the upper limit of normal. Renal function impairment (Creatinine clearance less than 50mL/min).
5. Unable to withhold concomitant medication for 48 hours prior to dosing and for the duration of confinement.
6. As a result of medical review, physical examination or screening investigations, the Medical Officer considers the participant unfit for the study.
7. Positive urine drug test or alcohol breath test at screening.
8. Use of macrolide antibiotics (eg. Erythromycin), azole antifungal agents (eg. Ketoconazole) within 30 days of study dosing.
9. Evidence of clinically relevant oral, cardiovascular, haematological, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric or skin disorder.
10. History of epilepsy.
11. History of coronary diseases, peripheral vascular diseases, cerebrovascular accident, transient ischaemic attack, uncontrolled hypertension or signs/symptoms of ischaemic heart disease.
12. Acute therapy for a serious infection within 30 days of study entry.
13. Positive screening test for Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody and HIV.
14. Have participated in a clinical trial or receipt of an experimental therapy within 60 days prior to dosing.
15. Blood donation of greater than 550 mL within 90 days before the first dose administration.
16. Consumption of grapefruit or grapefruit juice within 14 days prior to the first day of study confinement and through to completion of the confinement period.
17. Those who regularly drink more than four (4) units of alcohol daily (1 unit = 300 mL beer, 1 glass wine, 1 measure spirit) or those who may have difficulty abstaining from alcohol during the 36 hours prior to dose administration and until completion of blood sampling.
18. Unwilling or unable to fast for the 10 hours prior to dosing.
19. Women of child bearing potential, pregnant or breast feeding women.
20. Male partners of pregnant females.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method