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TD-0903 Pharmacokinetics Study in Healthy Participants With Supplemental Oxygenation

Primary Purpose

Acute Lung Injury (ALI) Due to Coronavirus Disease-2019 (COVID-19)

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Nezulcitinib (TD-0903) Dose A
Nezulcitinib (TD-0903) Dose B
Sponsored by
Theravance Biopharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lung Injury (ALI) Due to Coronavirus Disease-2019 (COVID-19) focused on measuring Acute lung injury, ALI, Coronavirus Disease-2019, COVID-19, Supplemental oxygen

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Body mass index (BMI) ≥ 18.0 and ≤ 35.0 kg/m2 and weighs at least 50 kg at screening
  • Medically healthy with no clinically significant medical history, physical examination, spirometry, laboratory profiles, vital signs or ECGs
  • Forced expiratory volume of 1 second (FEV1) ≥80% predicted at screening and prior to dosing
  • No clinically significant abnormalities in the results of laboratory
  • Female subjects must be either of non-childbearing potential or if of childbearing potential, subject must not be pregnant or breastfeeding, and must agree to use a highly effective birth control method
  • Male subjects must agree to use condoms to prevent potential fetal or partner exposure through seminal fluid, in addition to the use of highly effective pregnancy prevention measures with female partners of childbearing potential
  • Able to understand the correct technique for the use of the nebulizer device
  • Other inclusion criteria apply

Exclusion Criteria:

  • History or presence of clinically significant medical or psychiatric condition
  • Abnormal ECG measurements at screening
  • Any signs of respiratory tract infection within 6 weeks of screening
  • Has a current bacterial, parasitic, fungal, or viral infection; any infection requiring hospitalization or intravenous antibiotics within 6 months prior to screening
  • Has any condition of the oro-laryngeal or respiratory tract
  • History or presence of alcoholism or drug abuse
  • Positive urine drugs of abuse test
  • Positive urine or breath alcohol results
  • Uses or has used tobacco or nicotine-containing products (e.g., cigarettes, cigars, chewing tobacco, snuff, patches etc.) within 6 months prior to screening
  • Tests positive for active COVID-19
  • Additional exclusion criteria apply

Sites / Locations

  • Theravance Biopharma Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Administration Scenario A

Administration Scenario B

Administration Scenario C

Administration Scenario D

Arm Description

Single dose of TD-0903 at Dose A on Day 1, Period 1 delivered by nasal inhalation via nebulizer device with a high-flow nasal cannula delivering supplemental oxygen

Single dose of TD-0903 at Dose A on Day 1, Period 2 delivered by oral inhalation via nebulizer device with supplemental oxygen delivery via low-flow nasal cannula

Single dose of TD-0903 at Dose A on Day 1, Period 3 delivered by oral inhalation via nebulizer device with supplemental oxygen delivery via high-flow nasal cannula

Single dose of TD-0903 at Dose B on Day 1, Period 4 delivered by a route to-be-determined based on data from Scenarios A, B and C.

Outcomes

Primary Outcome Measures

AUC0-inf
The area under the concentration time curve from time 0 extrapolated to infinity (AUC0-inf) of TD-0903
AUC0-t
The area under the concentration time curve, from time 0 to the last observed non-zero concentration (AUC0-t) of TD-0903
Cmax
Maximum observed concentration (Cmax) of TD-0903 in plasma

Secondary Outcome Measures

Adverse Events
Number and severity of treatment emergent adverse events

Full Information

First Posted
October 12, 2021
Last Updated
December 8, 2021
Sponsor
Theravance Biopharma
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1. Study Identification

Unique Protocol Identification Number
NCT05091723
Brief Title
TD-0903 Pharmacokinetics Study in Healthy Participants With Supplemental Oxygenation
Official Title
Phase 1, Open-label Study to Assess the Pharmacokinetics and Safety of Inhaled Nezulcitinib (TD-0903) Administered in the Setting of Supplemental Oxygenation Scenarios in Healthy Participants
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
October 13, 2021 (Actual)
Primary Completion Date
November 24, 2021 (Actual)
Study Completion Date
November 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theravance Biopharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a Phase 1 pharmacokinetic (PK) study in healthy participants to assess the plasma pharmacokinetics, safety, and tolerability of a single inhaled dose of nezulcitinib (TD-0903) with supplemental oxygenation.
Detailed Description
A Phase 1, open-label, fixed-sequence, 4-period study to evaluate the plasma PK, safety and tolerability of single inhaled doses of nezulcitinib (TD-0903) administered under different supplemental oxygenation scenarios in healthy participants. Approximately 14 healthy adult male and female participants will receive a single inhaled dose of nezulcitinib using a nebulizer device on Day 1 of each administration period, under different supplementary oxygenations conditions. Administration A: Dose A nezulcitinib delivered by nasal inhalation via the Aerogen Solo with a high-flow nasal cannula circuit delivering supplemental oxygen, Administration B: Dose A nezulcitinib delivered by oral inhalation via the Aerogen Solo together with the Aerogen Ultra handheld device with a low-flow nasal cannula delivering supplemental oxygen, Administration C: Dose A nezulcitinib delivered by oral inhalation via the Aerogen Solo together with the Aerogen Ultra handheld device with a high-flow nasal cannula delivering supplemental oxygen, Administration D: Nezulcitinib delivered by inhalation. Route to be determined based on data from administration A-C.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lung Injury (ALI) Due to Coronavirus Disease-2019 (COVID-19)
Keywords
Acute lung injury, ALI, Coronavirus Disease-2019, COVID-19, Supplemental oxygen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Administration Scenario A
Arm Type
Experimental
Arm Description
Single dose of TD-0903 at Dose A on Day 1, Period 1 delivered by nasal inhalation via nebulizer device with a high-flow nasal cannula delivering supplemental oxygen
Arm Title
Administration Scenario B
Arm Type
Experimental
Arm Description
Single dose of TD-0903 at Dose A on Day 1, Period 2 delivered by oral inhalation via nebulizer device with supplemental oxygen delivery via low-flow nasal cannula
Arm Title
Administration Scenario C
Arm Type
Experimental
Arm Description
Single dose of TD-0903 at Dose A on Day 1, Period 3 delivered by oral inhalation via nebulizer device with supplemental oxygen delivery via high-flow nasal cannula
Arm Title
Administration Scenario D
Arm Type
Experimental
Arm Description
Single dose of TD-0903 at Dose B on Day 1, Period 4 delivered by a route to-be-determined based on data from Scenarios A, B and C.
Intervention Type
Drug
Intervention Name(s)
Nezulcitinib (TD-0903) Dose A
Intervention Description
TD-0903 Dose A
Intervention Type
Drug
Intervention Name(s)
Nezulcitinib (TD-0903) Dose B
Intervention Description
TD-0903 Dose B
Primary Outcome Measure Information:
Title
AUC0-inf
Description
The area under the concentration time curve from time 0 extrapolated to infinity (AUC0-inf) of TD-0903
Time Frame
Predose and at prespecified time points up to 48 hours after dosing on Day 1 of each period
Title
AUC0-t
Description
The area under the concentration time curve, from time 0 to the last observed non-zero concentration (AUC0-t) of TD-0903
Time Frame
Predose and at prespecified time points up to 48 hours after dosing on Day 1 of each period
Title
Cmax
Description
Maximum observed concentration (Cmax) of TD-0903 in plasma
Time Frame
Predose and at prespecified time points up to 48 hours after dosing on Day 1 of each period
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Number and severity of treatment emergent adverse events
Time Frame
Day 1 through 7 following dosing on Day 1 in each of 4 Periods

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Body mass index (BMI) ≥ 18.0 and ≤ 35.0 kg/m2 and weighs at least 50 kg at screening Medically healthy with no clinically significant medical history, physical examination, spirometry, laboratory profiles, vital signs or ECGs Forced expiratory volume of 1 second (FEV1) ≥80% predicted at screening and prior to dosing No clinically significant abnormalities in the results of laboratory Female subjects must be either of non-childbearing potential or if of childbearing potential, subject must not be pregnant or breastfeeding, and must agree to use a highly effective birth control method Male subjects must agree to use condoms to prevent potential fetal or partner exposure through seminal fluid, in addition to the use of highly effective pregnancy prevention measures with female partners of childbearing potential Able to understand the correct technique for the use of the nebulizer device Other inclusion criteria apply Exclusion Criteria: History or presence of clinically significant medical or psychiatric condition Abnormal ECG measurements at screening Any signs of respiratory tract infection within 6 weeks of screening Has a current bacterial, parasitic, fungal, or viral infection; any infection requiring hospitalization or intravenous antibiotics within 6 months prior to screening Has any condition of the oro-laryngeal or respiratory tract History or presence of alcoholism or drug abuse Positive urine drugs of abuse test Positive urine or breath alcohol results Uses or has used tobacco or nicotine-containing products (e.g., cigarettes, cigars, chewing tobacco, snuff, patches etc.) within 6 months prior to screening Tests positive for active COVID-19 Additional exclusion criteria apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Theravance Biopharma
Official's Role
Study Director
Facility Information:
Facility Name
Theravance Biopharma Investigational Site
City
Cypress
State/Province
California
ZIP/Postal Code
90630
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

Learn more about this trial

TD-0903 Pharmacokinetics Study in Healthy Participants With Supplemental Oxygenation

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