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Tests treatment safety and results for Amyotrophic Lateral Sclerosis
Official title Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Amisodin in Healthy Adult Subjects With Amyotrophic Lateral Sclerosis
ClinicalTrials.gov ID: NCT07221240
What this study is testing
What is Amisodin?
Amisodin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for amyotrophic lateral sclerosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- people must fulfill all of the following 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 oophorectomy or
You likely can't join if
- people 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...
- Any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first...
- 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...
- 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...
See the full eligibility criteria
- people must fulfill all of the following 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 people must follow...
- 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...
- Normal sinus rhythm (heart rate between 40 and 100 bpm, inclusive)
- QTcF interval ≤ 450 msec (males) or ≤ 460 msec (females)
- QRS interval \ 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.
- people 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.