A study in healthy subjects to see the effects of the test medicine on the body when given in fed or fasted state as a multiple dose
- Conditions
- Transthyretin (TTR) Amyloidosis (ATTR)Digestive System
- Registration Number
- ISRCTN11628974
- Lead Sponsor
- Eidos Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 28
1. Must provide written informed consent
2. Must be willing and able to communicate and participate in one cohort
3. Aged 18 to 65 years inclusive at the time of signing informed consent
4. Must agree to adhere to the contraception requirements
5. Healthy males or non-pregnant, non-lactating healthy females
6. Body mass index (BMI) of 18.0 to 32.0 kg/m² as measured at screening
7. Body weight >50 kg at screening
1. Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
2. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
3. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
4. Subjects with a history of cholecystectomy or gall stones
5. Subjects who do not have suitable veins for multiple venepunctures/cannulations as assessed by the investigator or delegate at screening
6. Evidence of current SARS-CoV-2 infection within 2 weeks of first IMP administration
7. Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator (laboratory parameters are listed in the clinical study protocol). Subjects with Gilbert’s Syndrome are allowed
8. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results
9. Females of childbearing potential including those who are pregnant or lactating (all female subjects must have a negative serum pregnancy test at screening and a negative highly sensitive urine pregnancy test at each admission)
10. Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1, or less than 5 elimination half-lives prior to Day 1, whichever is longer. Subjects enrolled in Cohort 1 will not be permitted to enrol in Cohort 2. Subjects who have received acoramidis in the previous Quotient Sciences study QSC204480 (AG10-009) are permitted to take part
11. Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood
12. Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g of paracetamol per day or HRT/hormonal contraception) in the 14 days before IMP administration. COVID-19 vaccines are accepted concomitant medications. Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as determined by the investigator
13. History of any drug or alcohol abuse in the past 2 years
14. Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type)
15. A confirmed positive alcohol breath test at screening or admission
16. Current smokers and those who have smoked within the last 12 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission
17. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
18. Confirmed positive drugs of abuse test result (drugs of abuse tests are listed in the clinical study protocol)
19. Male subjects with pregnant or lactating partners
20. Subjects who are, or are immediate family members of, a study site or Sponsor employee
21. Failure to satisfy the investigator of fitness to participate for any other reason
22. In the judgment of the investigator or Sponsor, has any clinically important ongoing medical condition or laboratory abnormality or other condition that might jeopardise the subject’s safety, increase their risk from participation, or interfere with the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Measurement of the PK parameters of acoramidis (AG10) and acoramidis-AG including but not limited to: Tmax, Cmax, Cmin (Day 7), Ctrough (Day 7), C24, AUC(0-tau), AUC(0-last) (Day 7), AUC(0-inf) (Day 7) and T1/2 (Day 7)<br>2. Assessment of dose accumulation of AG10 and acoramidis-AG for Cmax and AUC(0-tau) (Day 7 vs Day 1)
- Secondary Outcome Measures
Name Time Method