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Part A; Cohort 3 for Alzheimer Disease

Phase-Based Progress Estimates

1

Effectiveness

1

Safety

Celerion, Lincoln, NE

Alzheimer Disease+3 More

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Eligibility

18 - 65

All Sexes

What conditions do you have?

Select

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

1

1

1

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

1

1

1

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 - 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.

References

2022. "Safety and Pharmacokinetic Study of NPT 2042 Soft-gelatin Capsules Administered Orally to Healthy Adult Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05503511.

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