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Report for Clinical Trial NCT02934139

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of N91115 in Healthy Subjects

The present study is designed to assess the safety and tolerability of escalating, multiple ascending doses of Cavosonstat (N91115) in healthy subjects.

NCT02934139 Cystic Fibrosis
MeSH:Cystic Fibrosis

2 Interventions

Name: Cavosonstat

Description: CFTR modulator that stabilizes CFTR
Type: Drug
Group Labels: 4

Cavosonstat (N91115) 1200 mg Cavosonstat (N91115) 400 mg Cavosonstat (N91115) 600 mg Cavosonstat (N91115) 800 mg

Name: Placebo

Description: Matched placebo
Type: Other
Group Labels: 1

Placebo


Primary Outcomes

Description: Safety assessments based on clinical evaluations, laboratory assessments, and adverse events

Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Time: 14 days

Secondary Outcomes

Description: Pharmacokinetic parameter of N91115 and metabolites will be measured in urine.

Measure: Pharmacokinetic parameters of N91115 and metabolites (Amount of analyte excreted in the urine [Ae])

Time: 7 days

Description: Pharmacokinetic parameter of N91115 and metabolites will be measured in urine.

Measure: Pharmacokinetic parameters of N91115 and metabolites (% analyte excreted in the urine [Fe])

Time: 7 days

Description: Pharmacokinetic parameter of N91115 and metabolites will be measured in plasma.

Measure: Pharmacokinetic parameters of N91115 and metabolites (area under the curve [AUC])

Time: 7 days

Description: Pharmacokinetic parameter of N91115 and metabolites will be measured in plasma.

Measure: Pharmacokinetic parameters of N91115 and metabolites (maximum concentration [Cmax])

Time: 7 days

Description: Pharmacokinetic parameter of N91115 and metabolites will be measured in urine and plasma.

Measure: Pharmacokinetic parameters of N91115 and metabolites (clearance [CL])

Time: 7 days

Description: Pharmacokinetic parameter of N91115 and metabolites will be measured in plasma.

Measure: Pharmacokinetic parameters of N91115 and metabolites (accumulation index [Racc])

Time: 7 days

Description: Pharmacokinetic parameter of N91115 and metabolites will be measured in plasma.

Measure: Pharmacokinetic parameters of N91115 and metabolites (Terminal elimination half-life [t1/2])

Time: 7 days

Description: Pharmacokinetic parameter of N91115 and metabolites will be measured in plasma.

Measure: Pharmacokinetic parameters of N91115 and metabolites (time of maximum concentration [Tmax])

Time: 7 days

Description: Pharmacokinetic parameter of N91115 and metabolites will be measured in plasma.

Measure: Pharmacokinetic parameters of N91115 and metabolites (metabolite to parent exposure ratio [M/P ratio])

Time: 7 days

Description: Pharmacokinetic parameter of N91115 and metabolites will be measured in plasma.

Measure: Pharmacokinetic parameters of N91115 and metabolites (terminal elimination rate constant [lambda z])

Time: 7 days

Purpose: Basic Science

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 Q12H

Eligible subjects will be randomized in a 3:1 ratio to receive investigational medicinal product (IMP) N91115 (daily [QD] or every 12 hours [Q12H]) or matching placebo (QD or Q12H) for 7 days and will be followed for safety while housed in the clinical research unit (CRU) until discharge on Day 8. Pharmacokinetics will be followed from Study Day 1 through the morning of Study Day 8. --- Q12H ---

Eligible subjects will be randomized in a 3:1 ratio to receive investigational medicinal product (IMP) N91115 (daily [QD] or every 12 hours [Q12H]) or matching placebo (QD or Q12H) for 7 days and will be followed for safety while housed in the clinical research unit (CRU) until discharge on Day 8. Pharmacokinetics will be followed from Study Day 1 through the morning of Study Day 8. --- Q12H --- --- Q12H ---



HPO Nodes