Status:
COMPLETED
Safety, Tolerability and Pharmacokinetics of AM1476 in Healthy Subjects
Lead Sponsor:
AnaMar AB
Collaborating Sponsors:
Covance
Conditions:
Safety
Tolerability
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
This is a First in Human (FIH), double-blind, randomised, placebo-controlled study designed to evaluate safety, tolerability and pharmacokinetics (PK) of single and multiple ascending oral doses of AM...
Detailed Description
Part A (SAD); In the SAD part of the study, single oral doses of AM1476 will be administered in up to 9 sequential groups, each consisting of 8 subjects randomised to receive either AM1476 or placebo ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Males or females, of any race, between 18 and 60 years of age, inclusive.
- A body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive.
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital non-haemolytic hyperbilirubinemia \[eg, suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable) at Screening and/or Check-in (Day -1) as assessed by the Investigator (or designee).
- Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception as detailed in Appendix 4.
- Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
- Exclusion Criteria
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
- Any of the following observed in at least 2 of 3 ECG measurements performed:
- QTcF \> 450 msec.
- QRS duration \> 110 msec.
- PR interval \> 220 msec.
- findings which would make QTc measurements difficult or QTc data uninterpretable.
- Any history of additional risk factors for torsades de pointes (eg, heart failure, hypokalaemia, family history of long QT syndrome).
- Any history or current controlled or uncontrolled hypertension or systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg confirmed by repeat measurement.
- History of alcoholism or drug/chemical abuse within 2 years prior to Check-in (Day -1).
- Alcohol consumption of \> 21 units per week for males and \> 14 units per week for females. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits.
- Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at Screening or Check-in (Day -1).
- Positive hepatitis panel and/or positive human immunodeficiency virus test (Appendix 2).
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days prior to dosing.
- Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's Wort, within 30 days prior to dosing, unless deemed acceptable by the Investigator (or designee).
- Use or intend to use any prescription medications/products other than hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptives within 14 days prior to dosing, unless deemed acceptable by the Investigator (or designee).
- Use or intend to use slow release medications/products considered to still be active within 14 days prior to Check-in (Day -1), unless deemed acceptable by the Investigator (or designee).
- Use or intend to use any non-prescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to Check-in (Day -1), unless deemed acceptable by the Investigator (or designee).
- Use of tobacco- or nicotine-containing products within 3 months prior to Check-in (Day -1) or positive cotinine at Screening or Check-in (Day -1).
- Ingestion of poppy seeds, Seville orange, or grapefruit-containing foods or beverages within 7 days prior to Check-in (Day -1).
- Subjects who are vegetarians, vegans, or are unable to consume the high-fat breakfast (subjects who will participate in a food-effect evaluation only).
- Receipt of blood products within 2 months prior to Check-in (Day -1).
- Donation of blood from 3 months prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
- Poor peripheral venous access.
- Have previously completed or withdrawn from this study or any other study investigating AM1476, and have previously received AM1476.
- Subjects who are not willing to minimise or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) following administration of study drug until 2 weeks after the last dose.
- Subjects who, in the opinion of the Investigator (or designee), should not participate in this study.
Exclusion
Key Trial Info
Start Date :
December 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2021
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT04691115
Start Date
December 16 2020
End Date
December 8 2021
Last Update
August 2 2024
Active Locations (1)
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1
Covance Clinical Research Unit
Leeds, United Kingdom, LS2 9LH