MW151-101: First-in-human Study of MW151
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|ClinicalTrials.gov Identifier: NCT04120233|
Recruitment Status : Recruiting
First Posted : October 9, 2019
Last Update Posted : February 19, 2020
MW01-2-151SRM (=MW151), a small molecule, is being developed for the treatment of cognitive disorders. The development program is based on nonclinical evidence that MW151 improves neurocognitive outcomes in animal models of radiation-induced cognitive impairment, Alzheimer's disease, and other central nervous system (CNS) disorders.
The present study will provide safety and pharmacokinetic (PK) information on single ascending doses to support decisions for continued clinical development.
|Condition or disease||Intervention/treatment||Phase|
|Drug Toxicity||Drug: Placebo Drug: MW151, 10mg Drug: MW151, 20mg Drug: MW151, 40mg Drug: MW151, 80mg Drug: MW151, 160mg||Phase 1|
The primary objective of this trial is to assess the safety and tolerability of single ascending doses of MW151 when administered orally to healthy adults.
Subjects will be screened prior to inpatient admission. Subjects will be admitted to the inpatient clinic on the day prior to dosing (Day -1) and will remain in the unit until discharge on Day 3. A follow-up visit will be done on Day 7. A single dose of study drug or placebo will be administered on Day 1. Forty healthy adult male and female subjects will be randomly assigned to one of 5 dose cohorts (8 subjects each). Each subject will receive a single dose of MW151 (10-160mg) or placebo under fasted conditions.
Following a review of safety and tolerability data for the first 24 hours of dosing in each cohort (including reported adverse events (AEs), physical examination findings, clinical laboratory results, vital signs, and electrocardiograms (ECGs), the remaining 6 subjects will be randomized in a 5:1 ratio. Dosing of the remaining subjects in a cohort may proceed after review of sentinel subject safety data collected during the first 24 hours of dosing and determination that no stopping rules are met. The remaining subjects in each cohort will be dosed sequentially, not simultaneously.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Dose-escalation study.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Data from cohorts will be reviewed in a blinded manner.|
|Official Title:||A Phase 1a, Double-Blind, Randomized, Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of MW151 Administered Orally to Healthy Volunteers|
|Actual Study Start Date :||October 22, 2019|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2021|
Placebo Comparator: Placebo
Participants will receive placebo.
Matched placebo administered orally
Experimental: Dose 1
Participants will receive 10 mg of MW151.
Drug: MW151, 10mg
10 mg MW151, 1 x 10mg capsule administered orally
Experimental: Dose 2
Participants will receive 20mg of MW151.
Drug: MW151, 20mg
20 mg MW151, 1 x 20mg capsule administered orally
Experimental: Dose 3
Participants will receive 40mg of MW151.
Drug: MW151, 40mg
40 mg MW151, 2 x 20mg capsule administered orally
Experimental: Dose 4
Participants will receive 80mg of MW151.
Drug: MW151, 80mg
80 mg MW151, 1 x 80mg capsule administered orally
Experimental: Dose 5
Participants will receive 160mg of MW151.
Drug: MW151, 160mg
160 mg MW151, 2 x 80mg capsule administered orally
- Percentage of participants experiencing drug-related serious adverse events. [ Time Frame: Seven days ]Percentage of participants experiencing drug-related serious adverse events.
- Maximum Drug Concentration (Cmax) [ Time Frame: Seven days ]Peak serum concentration of MW151.
- Time to Maximum Drug Concentration (Tmax) [ Time Frame: Seven days ]Time required to reach the maximum serum concentration of MW151.
- Overall Drug Exposure (AUC) [ Time Frame: Seven days ]Overall drug exposure (mg*h/L) determined by calculating the area under the curve (AUC) from a plasma drug concentration-time curve.
- Drug Half-Life (T1/2) [ Time Frame: Seven days ]Time at which the concentration of MW151 is at half the maximum concentration.
- Elimination Rate Constant (Kel) [ Time Frame: Seven days ]Fraction of MW151 eliminated per unit of time (mathematical determination).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04120233
|Contact: Linda J Van Eldik, PhDfirstname.lastname@example.org|
|United States, North Carolina|
|Duke Clinical Research Institute||Recruiting|
|Durham, North Carolina, United States, 27705|
|Contact: Jeffrey T Guptill, MD 919-668-8445 Jeffrey.email@example.com|
|Principal Investigator: Jeffrey T Guptill, MD|
|Principal Investigator:||Linda J Van Eldik, PhD||University of Kentucky|