Part A; Cohort 3 for Alzheimer Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Celerion, Lincoln, NE
Alzheimer Disease+3 More
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

Study NPT 2042 CL 101 is a first in human (FIH) study to evaluate the safety and pharmacokinetics (PK) of single and repeated ascending doses of NPT 2042 in healthy adult male and female subjects.

Eligible Conditions

  • Epilepsy, Intractable
  • Alzheimer Disease
  • Aura

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Alzheimer Disease

Study Objectives

4 Primary · 8 Secondary · Reporting Duration: 0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose

Hour 36
Dose proportionality
Pharmacokinetic AUCinf
Pharmacokinetic AUClast
Pharmacokinetic CL/F
Pharmacokinetic Cmax
Pharmacokinetic Tmax
Pharmacokinetic VzF
Pharmacokinetic half-life (t1/2)
Up to 11 days
Number of participants with abnormal lab test results
Number of participants with abnormal vital signs
Number of participants with adverse events
Up to 7 days
Number of participants with abnormal ECG

Trial Safety

Safety Progress

1 of 3

Other trials for Alzheimer Disease

Trial Design

6 Treatment Groups

Part B; Cohort 2
1 of 6
Part A; Cohort 1
1 of 6
Part A; Cohort 3
1 of 6
Part A; Cohort 2
1 of 6
Part B; Cohort 1
1 of 6
Part B; Cohort 3
1 of 6
Experimental Treatment

48 Total Participants · 6 Treatment Groups

Primary Treatment: Part A; Cohort 3 · Has Placebo Group · Phase 1

Part B; Cohort 2
Drug
Experimental Group · 1 Intervention: NPT 2042 (bumetanide analog) or Matching Placebo · Intervention Types: Drug
Part A; Cohort 1
Drug
Experimental Group · 1 Intervention: NPT 2042 (bumetanide analog) or Matching Placebo · Intervention Types: Drug
Part A; Cohort 3
Drug
Experimental Group · 1 Intervention: NPT 2042 (bumetanide analog) or Matching Placebo · Intervention Types: Drug
Part A; Cohort 2
Drug
Experimental Group · 1 Intervention: NPT 2042 (bumetanide analog) or Matching Placebo · Intervention Types: Drug
Part B; Cohort 1
Drug
Experimental Group · 1 Intervention: NPT 2042 (bumetanide analog) or Matching Placebo · Intervention Types: Drug
Part B; Cohort 3
Drug
Experimental Group · 1 Intervention: NPT 2042 (bumetanide analog) or Matching Placebo · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose
Closest Location: Celerion · Lincoln, NE
2011First Recorded Clinical Trial
7 TrialsResearching Alzheimer Disease
198 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are female and not of child-bearing potential.
You are able to swallow capsules.
You are a minimum of 50 kg or 45 kg for males and females respectively.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.