None listed
Conditions
Brief summary
This research project is being conducted to look at the safety, tolerability and pharmacokinetics (PK, how the human body processes a substance) of iCo-019 (oral Amphotericin B when given to healthy volunteers as multiple oral doses for to 10 consecutive days.
Interventions
iCo-019 (oral Amphotericin B) 100mg gelatin capsule taken orally.
Cohort 1: 1 x 100 mg capsule or 1x placebo capsule for 10 days once per day
Cohort 2: 4 x 100 mg capsule or 4x placebo capsule for 10 days once per day
A Safety Evaluating Committee (SEC) will review data from the first cohort (100 mg of oral Amphotericin B or placebo) once completed and make a recommendation whether it is safe to proceed with multiple dosing of 400 mg of oral Amphotericin B or placebo in the second cohort.
Adher
iCo-019 (oral Amphotericin B) 100mg gelatin capsule taken orally. Cohort 1: 1 x 100 mg capsule or 1x placebo capsule for 10 days once per day Cohort 2: 4 x 100 mg capsule or 4x placebo capsule for 10 days once per day A Safety Evaluating Committee (SEC) will review data from the first cohort (100 mg of oral Amphotericin B or placebo) once completed and make a recommendation whether it is safe to proceed with multiple dosing of 400 mg of oral Amphotericin B or placebo in the second cohort. Adherence to the study treatments will be monitored by inpatient stay and observation; participants in will be confined to the study unit from check-in on Day -1 through to discharge at 48-hour post last dose.
Sponsors
iCo Therapeutics Inc
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy subjects as demonstrated by physical examination, medical history and overall assessment by the Investigator, in consultation with the medical monitor (if required) 2. Adult male or female volunteers, aged 18-55 years inclusive 3. BMI of 18.0 kg/m2 to 30.0 kg/m2 4. Not taking any prescription medication (with the exception of hormonal contraceptives for women of child-bearing potential [WOCBP]) within 14 days prior to study drug administration until 10 days after dosing; no use of Over-the-counter (OTC) medication (including paracetamol), or herbal and dietary health products within 48 hours prior to study drug administration until 10 days after dosing. Coated paracetamol may be used at the discretion of the investigator (or delegate). 5. Women who are postmenopausal for 1 year or more (post-menopausal is defined as documented amenorrhea for at least 1 year with an FSH >/= 40 mIU/ml if menses has occurred within 2 years); women who are surgically sterilized; WOCBP who are nonlactating and using a highly effective form of birth control during the course of the study and for 30 days after the treatment period (i.e. established use of oral, injected, or implanted hormonal methods of contraception in combination with a barrier method; placement of an intrauterine device (IUD) or intrauterine system (IUS) in combination with a barrier method; sterilized male partner (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate) in combination with a barrier method; true abstinence) and have a negative beta-HCG result (human chorionic gonadotropin in serum or urine) at screening and check-in at Day-1. 6. Male subjects must agree to practice abstinence; be surgically sterilized; or use a medically acceptable method of contraception/birth control if they have a female partner of child-bearing potential, as well as having the female partner use an effective form of contraception, throughout the study duration and for 90 days after the study is completed. Male participants must refrain from sperm donation for the purposes of conception while enrolled in this study and for a period of 3 months (the approximate duration of spermatogenesis) following drug exposure 7. Able to read and understand the Informed Consent Form 8. Willing to participate in the study
Exclusion criteria
1. Any medical condition or prior therapy that, in the opinion of the investigator and in consultation with the medical monitor (if required), would make the subject unsuitable for this study 2. Inability to swallow capsules 3. Pregnant or breastfeeding, or planning to conceive until at least 30 days after the administration of Investigational Product 4. Surgery within the previous 3 months (except for minor cosmetic or dental procedures) 5. Symptoms of a clinically significant illness (eg, gastrointestinal illness, infection such as influenza, upper respiratory tract infection) in the four weeks before the study drug dosing that, in the opinion of the Investigator, may influence the outcome of the study 6. Average weekly alcohol intake that exceeds 21 units per week (males) or 14 units (females) per week, or are unwilling to stop alcohol consumption for 2 days prior to study drug dosing until 10 days after dosing (one unit is equivalent to a half-pint (285 mL) of beer or 1 (25 mL) measure of spirits or 1 glass (125 mL) of wine). 7. Positive alcohol breathalyzer test at screening or check-in at Day-1 8. Positive urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates, cotinine) at screening or check-in at Day-1 9. Use of more than 4 tobacco- or nicotine-containing products per month within 6 months prior to first study dose, or unwilling to refrain from the use of such products from Screening until completion of the final study visit; 10. Lactose intolerance or other gastrointestinal disease that in the opinion of the Investigator and in consultation with the medical monitor (if required), may alter the amount and rate of drug absorption (e.g. diarrhea, IBS, Celiac disease) 11. Any serious medical condition; e.g., kidney, liver or cardiac disease (outside standard range of results), asthma, diabetes, thyroid disease, angioedema, hypertension, bleeding disorder, malignancy, seizure, neutropenia, AIDS, etc. 12. Any condition, occupational reason or other responsibility that, in the judgment of the Investigator, would jeopardize the safety or rights of a volunteer, or render the subject unable to comply with the protocol 13. Participation in another clinical trial and/or treatment received with any investigational agent within one month before the initial dose of study medication 14. Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's return for follow-up visits on schedule.
Outcome results
None listed