Amyotrophic Lateral Sclerosis study: Amisodin
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, taken by mouth once daily, 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
- The study aims to find out whether Amisodin is safe, well‑tolerated, and how it is absorbed and cleared from the body.
- Who it's for
- Healthy adults who meet the study’s eligibility criteria.
- What's involved
- Participants will be randomly assigned to receive either Amisodin or a placebo by mouth, either as a single dose or multiple doses, with some receiving the drug with food to see if food changes its effect.
- Time commitment
- The trial involves several clinic visits over a short period (typically a few weeks) for dosing and safety check‑ups.
- 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
- 1\. Healthy, adult, male or female (of non-childbearing potential only)\ , 18 55 years of age, inclusive, at the screening visit.
- 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
- Seated blood pressure is ≥ 90/50 mmHg and ≤ 140/90 mmHg
- Liver function tests at or below limit or normal range
You likely can't join if
- 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.
- Any drugs that prolong the QT/QTc interval within 14 days (or 5 half lives, whichever is longer) prior to the first dosing. 12\.
See the full eligibility criteria
- 1\. Healthy, adult, male or female (of non-childbearing potential only)\ , 18 55 years of age, inclusive, at the screening visit.
- 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
- Seated blood pressure is ≥ 90/50 mmHg and ≤ 140/90 mmHg
- Liver function tests at or below limit or normal range
- 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.
- 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\.
The study team makes the final eligibility decision.
Where it is enrolling
- 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, but 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?
This study is enrolling now at Baltimore, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.