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

Completed

Conditions: preventative treatment of a decline in brain functions after surgery
10029305

Registration Number: NL-OMON51342

Lead Sponsor: Monument Therapeutics Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 26

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 <=100 kg, inclusive, at screening.
5. At screening, females must not be pregnant or lactating, or must be of
nonchildbearing potential (either surgically sterilized or physiologically
incapable of becoming pregnant, or at least 1 year postmenopausal [follicle
stimulating hormone testing]); nonpregnancy will be confirmed for all females
by a negative serum pregnancy test at screening, and admission.

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).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To characterize the safety and tolerability of MT1980 in humans</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To provide information on the systemic bioavailability of study drug from a<br /><br>single oral dose of MT1980<br /><br>- To provide information on the amount of study drug in cerebrospinal fluid<br /><br>(CSF) from a single oral dose of MT1980<br /><br>- To provide information on the amount of study drug in CSF from a single oral<br /><br>dose of MT1980</p><br>