Ignite Creation Date:
2024-05-06 @ 3:16 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04576325
Status:
COMPLETED
Last Update Posted:
2021-11-18
First Post:
2020-09-25
Brief Title:
Pharmacokinetic Profile of Voriconazole Inhalation Powder in Adult Subjects With Asthma
Sponsor:
TFF Pharmaceuticals Inc
Organization:
TFF Pharmaceuticals Inc
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study Evaluating the Safety Tolerability and Pharmacokinetic Profile of Voriconazole Inhalation Powder in Adult Subjects With Asthma
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 1b randomized double-blind placebo-controlled trial to evaluate the safety tolerability and pharmacokinetic profiles of voriconazole inhalation powder in adult subjects with well-controlled asthma This study will involve 2 cohorts
Detailed Description:
This is a Phase 1b randomized double-blind placebo-controlled trial to evaluate the safety tolerability and pharmacokinetic PK profiles of voriconazole inhalation powder VIP in adult subjects with well-controlled Step 2 or Step 3 asthma This study will involve a minimum of 2 cohorts The first 2 subjects randomized into each cohort will be sentinel subjects ie one assigned to VIP and one assigned to placebo If study drug is deemed safe by the PI the remaining 6 subjects 5 on VIP and 1 on placebo may be enrolled
In Cohort 1 8 eligible subjects will be randomized in a 31 ratio 6 on active and 2 on placebo to receive 7 doses BID over 35 days of 40mg VIP or inhaled placebo Following completion of Cohort 1 and after dose escalation has been approved by the SMC Cohort 2 may begin
In Cohort 2 8 eligible subjects will be randomized in a 31 ratio to receive 7 doses BID over 35 days of 80 mg VIP or placebo Doses will be administered twice daily every 12 1 hours
A third cohort with the same design and number of subjects may be initiated if there are safety or other findings from Cohort 2 that warrant investigation of an intermediary dose eg VIP 60 mg BID The decision to initiate this potential 3rd cohort will be made by the Sponsor in collaboration with the safety monitoring committee SMC A sentinel design will not be required for this cohort
Following a variable length Screening period all subjects will be domiciled in a clinical research facility from the Check-In Day Day -1 and will remain domiciled until the morning of Day 5 A follow-up phone call or clinic visit depending on best practices at the time for Coronavirus Disease 2019 COVID-19 precautions will be made one week later to assess subject status and record any adverse events AEs
Safety will be assessed by monitoring AEs clinical laboratory tests vital signs pulse oximetry spirometry 12-lead ECGs and physical examinations Blood PK will be assessed from serial blood collections following Dose 1 and Dose 7 Study treatment stopping rules for individual subjects will be based on AEs SAEs required changes during the treatment period to asthma medications spirometry measure of forced expiratory volume at 1 second FEV1 and increases in QTcF values on ECG
The SMC will review the safety information accrued during the study and will be responsible for reviewing Cohort 1 safety information before authorizing dose escalation to Cohort 2
In Cohort 1 8 eligible subjects will be randomized in a 31 ratio 6 on active and 2 on placebo to receive 7 doses BID over 35 days of 40mg VIP or inhaled placebo Following completion of Cohort 1 and after dose escalation has been approved by the SMC Cohort 2 may begin
In Cohort 2 8 eligible subjects will be randomized in a 31 ratio to receive 7 doses BID over 35 days of 80 mg VIP or placebo Doses will be administered twice daily every 12 1 hours
A third cohort with the same design and number of subjects may be initiated if there are safety or other findings from Cohort 2 that warrant investigation of an intermediary dose eg VIP 60 mg BID The decision to initiate this potential 3rd cohort will be made by the Sponsor in collaboration with the safety monitoring committee SMC A sentinel design will not be required for this cohort
Following a variable length Screening period all subjects will be domiciled in a clinical research facility from the Check-In Day Day -1 and will remain domiciled until the morning of Day 5 A follow-up phone call or clinic visit depending on best practices at the time for Coronavirus Disease 2019 COVID-19 precautions will be made one week later to assess subject status and record any adverse events AEs
Safety will be assessed by monitoring AEs clinical laboratory tests vital signs pulse oximetry spirometry 12-lead ECGs and physical examinations Blood PK will be assessed from serial blood collections following Dose 1 and Dose 7 Study treatment stopping rules for individual subjects will be based on AEs SAEs required changes during the treatment period to asthma medications spirometry measure of forced expiratory volume at 1 second FEV1 and increases in QTcF values on ECG
The SMC will review the safety information accrued during the study and will be responsible for reviewing Cohort 1 safety information before authorizing dose escalation to Cohort 2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None