A two-part, single dose, randomized, single-blinded, placebo controlled, phase I study to assess the safety and pharmacokinetics of oral MT1980 in healthy volunteers when dosed in the fasted state

A two-part, single dose, randomized, single-blinded, placebo controlled, phase I study to assess the safety and pharmacokinetics of oral MT1980 in healthy volunteers when dosed in the fasted state - Safety and CSF sampling PK study of MT1980 vs placebo

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51342

Enrollment

Registered

2022-04-26

Start date

2022-05-31

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

preventative treatment of a decline in brain functions after surgery preventative treatment of a decline in brain functions after surgery

Interventions

Part 1: once 140 mg MT1980 or placebo Part 2: once between 25 mg and 250 mg MT1980 based on the results from Part 1 or placebo

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Sex: male or female; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal. 2. Age: 18 to 65 years, inclusive, at screening. 3. Body mass index: 18.0 to 30.0 kg/m2, inclusive, at screening. 4. Weight: >=50 kg and

Exclusion criteria

Exclusion criteria: 1. Previous randomization in the current study. 2. Participation in a drug study within 30 days prior to drug administration in the current study. Participation in 4 or more other drug studies in the 12 months prior to drug administration in the current study. 3. Subjects who are contract research organization (CRO) employees, or immediate family members of a clinical research center or Sponsor employee. 4. History of drug or alcohol dependency or abuse (including soft drugs like cannabis products) within the 2 years prior to screening. 5. Average intake of more than 24 units of alcohol per week (1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits).

Design outcomes

Primary

Measure	Time frame
To characterize the safety and tolerability of MT1980 in humans	—

Secondary

Measure	Time frame
- To provide information on the systemic bioavailability of study drug from a single oral dose of MT1980 - To provide information on the amount of study drug in cerebrospinal fluid (CSF) from a single oral dose of MT1980 - To provide information on the amount of study drug in CSF from a single oral dose of MT1980	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)