Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Amisodin in Healthy Adult Subjects With Amyotrophic Lateral Sclerosis
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Amisodin in Healthy Adult Subjects
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 55 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 7 days
- Procedures mentioned: Heart tracing (ECG), Physical exams, Pills
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "In Part 2 (MAD), subjects will receive Amisodin or placebo once daily for 7 days under fasting conditions."
- "Safety assessments will include adverse events (AEs), ECGs, vital signs, laboratory tests, physical examinations, and C-SSRS evaluations, while plasma samples will be collected to evaluate PK."
- "The capsules will be opened and mixed with 60mL of water."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the safety of Amisodin taken by mouth and how the body handles it, compared with a placebo (a pill with no study drug). It will test single and repeated doses and how food affects the drug. Although the title mentions ALS, the study details say it is for healthy adults ages 18 to 55.
Researchers will evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered Amisodin in healthy adult subjects through a randomized, double-blind, placebo-controlled Phase 1 study consisting of two parts: single ascending dose (SAD) and multiple ascending dose (MAD). The food effect will be assessed in one cohort in Part1. Approximately 48 healthy, adult subjects are planned to be enrolled in total. Subjects will participate in only one part and one cohort.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 18 to 55 years old.
- Women must be unable to become pregnant: have had a listed sterilization surgery at least 6 months before dosing, or have had no periods for at least 1 year after menopause, with a blood test to confirm.
- Men must follow the study's birth control rules and not donate sperm until 90 days after the last dose.
- Be a nonsmoker and have used no nicotine products for at least 3 months before dosing.
- Have a BMI (a measure of weight compared with height) of at least 18 but less than 32.
- Be healthy based on your health history, exam, and tests. Blood pressure must be 90/50 to 140/90, and liver and kidney tests must meet study limits.
- Have a heart tracing test that meets the study's rules, including a regular heartbeat of 40 to 100 beats per minute.
- Understand the consent form and be willing and able to follow study rules.
Who can't join
- Have a major medical, mental health, or emotional problem, or another condition that could affect study results or make joining unsafe. The study doctor may also rule out participation for other reasons.
- Have had alcohol or drug abuse in the past 2 years, or test positive for drugs or alcohol at screening or the first check-in.
- Have an allergy or unusual reaction to related drugs, study drug ingredients, or antihistamines (allergy medicines), or an allergy to bandages or medical tape.
- Be able to become pregnant, have a positive pregnancy test, or be breastfeeding.
- Test positive for HIV, hepatitis B, or hepatitis C.
- Be unable to avoid medicines, herbs, and vitamins starting 14 days before dosing. Some drugs need a longer break, including 28 days for certain drugs that change how the body handles medicines.
- Have followed a diet in the past 30 days that does not fit the study diet.
- Have donated blood or lost a large amount of blood within 56 days, donated plasma within 7 days, or been in another clinical study within 90 days before dosing. The 90 days starts from the last dose or blood draw in that study, whichever was later.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: Subjects must fulfill all of the following inclusion criteria to be eligible for participation in the study: * 1\. Healthy, adult, male or female (of non-childbearing potential only)\*, 18 55 years of age, inclusive, at the screening visit. * Females of non-childbearing potential are defined as follows: * Females who have undergone one of the following sterilization procedures at least 6 months prior to the first dosing: o Hysteroscopic sterilization o Bilateral tubal ligation or bilateral salpingectomy o Hysterectomy * Bilateral oophorectomy or * Females who are postmenopausal with amenorrhea for at least 1 year prior to the first dosing and have follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status. 2. Male subjects must follow protocol specified contraception guidance as described in Section 7.4.5 Contraception Requirements and agree to refrain from sperm donation until 90 days after the last dosing. 3. Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing based on subject self-reporting. 4\. Body mass index (BMI) ≥ 18.0 and \< 32.0 kg/m2 at the screening visit. 5. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, or vital signs, as deemed by the PI or designee at the screening visit, including the following: * Seated blood pressure is ≥ 90/50 mmHg and ≤ 140/90 mmHg * Liver function tests at or below limit or normal range * Estimated glomerular filtration rate (estimated by Modification of Diet in Renal Disease Study equation \[MDRD\] method) ≥ 90 mL/min/1.73 m² 6. No ECG findings of clinical significance as judged by the PI or qualified designee at the screening visit and at first check in, including each criterion as listed below: * Normal sinus rhythm (heart rate between 40 and 100 bpm, inclusive) * QTcF interval ≤ 450 msec (males) or ≤ 460 msec (females) * QRS interval \< 110 msec; if \> 110 msec, result will be confirmed by a manual over read * PR interval ≤ 210 msec 7. Understands the study procedures in the informed consent form (ICF) and be willing and able to comply with the protocol. Exclusion Criteria: Subjects must not be enrolled in the study if they meet any of the following criteria: * 1\. Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study. 2\. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee. 3. History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study. 4. History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing. 5. History or presence of hypersensitivity or idiosyncratic reaction to compounds related to the study drug, study drug excipients, or antihistamines. 6\. Allergy to band aids, adhesive dressing, or medical tape. 7. Female subjects of childbearing potential. 8. Female subject with a positive pregnancy test at the screening visit or at first check-in or who is lactating. 9. Positive urine drug or serum alcohol results at the screening visit or first check-in. 10. Positive results at the screening visit for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV). 11. Unable to refrain from or anticipates the use of: • Any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing. • Any drugs known to be significant inducers of cytochrome P450s (CYP) and/or P-glycoprotein (P-gp), including St. John's Wort, for 28 days prior to the first dosing. • Any drugs that prolong the QT/QTc interval within 14 days (or 5 half lives, whichever is longer) prior to the first dosing. 12\. Has been on a diet incompatible with the on-study diet, in the opinion of the PI or designee, within the 30 days prior to the first dosing. 13. Donation of blood or significant blood loss within 56 days prior to the first dosing. 14. Plasma donation within 7 days prior to the first dosing 15. Participation in another clinical study within 90 days prior to the first dosing. The 90-day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of the current study. 16\. Any other reason determined by the PI or designee, in their opinion, that would prevent the subject's participation in the study.
Study sites (1)
MD
- Pharmaron, Inc. · Baltimore, MD 21201James Phillips · Study contact · +82 051-583-8703 · dntpdus@prgst.comMore trials in Baltimore