Stabilized Isoamyl Nitrite (SIAN) for Cyanide Poisoning

Phase-Based Progress Estimates

Effectiveness

Safety

Cyanide PoisoningStabilized Isoamyl Nitrite (SIAN) - Drug

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Eligibility

18 - 45

All Sexes

What conditions do you have?

Select

Eligibility

18 - 45

All Sexes

What conditions do you have?

Select

Study Summary

This trial is testing a new nasal spray made from a chemical called isamyl nitrite. They want to see if it's safe and how it affects the body.

Eligible Conditions

Cyanide Poisoning

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

2 Primary · 27 Secondary · Reporting Duration: Through 360 minutes post-dose

Through 360 minutes post-dose

Methemoglobin (MetHb) level

PD Endpoint: AUC0-t of MetHb

PD Endpoint: Area under the effect curve (AUEC(0-t)) of the fraction of MetHb (%)

PD Endpoint: Cmax of MetHb

PD Endpoint: The maximum change from baseline (Emax) of MetHb

PD Endpoint: Time of reaching Emax (TEmax) of MetHb

PD Endpoint: Time to recovery to baseline values of MetHb

PD Endpoint: t1/2 of MetHb

Through 59 minutes post-dose

PK Endpoint: AUC 0-t plus the additional area extrapolated to infinity (AUC 0-inf) of IAA

PK Endpoint: Apparent first order terminal elimination half-life (t 1/2) of IAA

PK Endpoint: Area under the concentration-time curve from time 0 to 10 minutes post-dose (AUC 0-10min) of IAA

PK Endpoint: Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC 0-last) of IAA

PK Endpoint: Maximum observed concentration (Cmax) of Isoamyl Alcohol (IAA metabolite)

PK Endpoint: Time at which Cmax occurs (Tmax) of IAA

Through 60 minutes Post-Dose

Safety Endpoint: Orthostatic Hypotension

Hour 8

PD Endpoint: Emax for HR (beats/min)

PD Endpoint: Emax for HR (heart rate) (beats/min)

PD Endpoint: Emax for SpO2 by pulse oximetry

PD Endpoint: TEmax for HR (beats/min)

PD Endpoint: TEmax for SpO2 by pulse oximetry

PD Endpoint: Time to recovery to baseline SpO2 (%)

PD Endpoint: Time to recovery to baseline for HR (beats/min)

Bronchial Provocation Tests

PD Endpoint: for BP maximum change from TEmax

PD Endpoint: for BP maximum change from baseline (Emax)

Through Day 8

Related Serious Adverse Events (SAEs)

Safety Endpoint: Adverse Events (AEs)

Safety Endpoint: Toxicity grade 1 or higher of clinical laboratories

Safety Endpoint: Toxicity grade 1 or higher of vital signs

Trial Safety

Safety Progress

1 of 3

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Moxonidine Pill

Moxonidine

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Trial Design

7 Treatment Groups

Cohort 3 SIAN

1 of 7

Cohort 1 SIAN

1 of 7

Cohort 2 SIAN

1 of 7

Cohort 4 SIAN

1 of 7

Cohort 6 SIAN

1 of 7

Cohort 7 SIAN

1 of 7

Cohort 5 SIAN

1 of 7

Experimental Treatment

70 Total Participants · 7 Treatment Groups

Primary Treatment: Stabilized Isoamyl Nitrite (SIAN) · No Placebo Group · Phase 1

Cohort 3 SIAN

Drug