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Single and Multiple Ascending Dose Study of TD-8236 by Inhalation

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ClinicalTrials.gov Identifier: NCT03652038
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma

Brief Summary:
This is a Phase 1, randomized, double-blinded, placebo controlled study. The study consists of 2 parts: Part A is a single ascending dose (SAD) study in healthy subjects and Part B is a multiple ascending dose (MAD) study in subjects with stable, mild asthma.

Condition or disease Intervention/treatment Phase
Asthma Drug: TD-8236 (for SAD) Drug: TD-8236 (for MAD) Drug: Placebo (for SAD) Drug: Placebo (for MAD) Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, 2-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TD-8236 by Inhalation of Single Ascending Doses in Healthy Subjects and Multiple Ascending Doses in Subjects With Stable, Mild Asthma
Actual Study Start Date : November 7, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: TD-8236 for SAD
6 out of 8 subjects per cohort (up to 5 cohorts) will be randomized to receive TD-8236
Drug: TD-8236 (for SAD)
The study drug will be administered as a single dose via inhaler device.

Placebo Comparator: Placebo for SAD
2 out of 8 subjects per cohort (up to 5 cohorts) will be randomized to receive placebo
Drug: Placebo (for SAD)
The placebo will be administered as a single dose via inhaler device.

Experimental: TD-8236 for MAD
6 out of 8 subjects per cohort (up to 6 cohorts) will be randomized to receive TD-8236. Ten subjects in biomarker cohort will be randomized to receive TD-8236.
Drug: TD-8236 (for MAD)
The study drug will be administered for a total of 7 days via inhaler device.

Placebo Comparator: Placebo for MAD
2 out of 8 subjects per cohort (up to 6 cohorts) will be randomized to receive placebo. Ten subjects in biomarker cohort will be randomized to receive placebo.
Drug: Placebo (for MAD)
The placebo will be administered for a total of 7 days via inhaler device.




Primary Outcome Measures :
  1. To assess the safety and tolerability of SAD of TD-8236 by assessing the number, severity and type of treatment emergent adverse events [ Time Frame: Day 1 through Day 8 ]
  2. To assess the safety and tolerability of MAD of TD-8236 by assessing the number, severity and type of treatment emergent adverse events [ Time Frame: Day 1 through Day 14 ]

Secondary Outcome Measures :
  1. Pharmacokinetics (PK) of TD-8236 when given as a Single Ascending Dose (SAD): Area under the plasma concentration-time curve (AUC) [ Time Frame: Day 1 through Day 4 ]

    Multiple PK variables of TD-8236 will be assessed during SAD and may include, but are not limited to:

    Area under the plasma concentration-time curve (AUC)


  2. Pharmacokinetics (PK) of TD-8236 when given as a Single Ascending Dose (SAD): Maximum observed concentration (Cmax) [ Time Frame: Day 1 through Day 4 ]

    Multiple PK variables of TD-8236 will be assessed during SAD and may include, but are not limited to:

    Maximum observed concentration (Cmax)


  3. Pharmacokinetics (PK) of TD-8236 when given as a Single Ascending Dose (SAD): Time to reach maximum observed concentration (Tmax) [ Time Frame: Day 1 through Day 4 ]

    Multiple PK variables of TD-8236 will be assessed during SAD and may include, but are not limited to:

    Time to reach maximum observed concentration (Tmax)


  4. Pharmacokinetics (PK) of TD-8236 when given as a Multiple Ascending Dose (MAD): Area under the plasma concentration-time curve (AUC) [ Time Frame: Day 1 through Day 9 ]

    Multiple PK variables of TD-8236 will be assessed during MAD and may include, but are not limited to:

    Area under the plasma concentration-time curve (AUC)


  5. Pharmacokinetics (PK) of TD-8236 when given as a Multiple Ascending Dose (MAD): Maximum observed concentration (Cmax) [ Time Frame: Day 1 through Day 9 ]

    Multiple PK variables of TD-8236 will be assessed during MAD and may include, but are not limited to:

    Maximum observed concentration (Cmax)


  6. Pharmacokinetics (PK) of TD-8236 when given as a Multiple Ascending Dose (MAD): Time to reach maximum observed concentration (Tmax) [ Time Frame: Day 1 through Day 9 ]

    Multiple PK variables of TD-8236 will be assessed during MAD and may include, but are not limited to:

    Time to reach maximum observed concentration (Tmax)




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female, 18 - 60 years old
  • Willing and able to give informed consent and comply with the study
  • Body mass index (BMI) 18 to 32 kg/m2 and weighs at least 50 kg
  • Women of child bearing potential must have a negative pregnancy test and use a highly efficient birth control method
  • Pre-bronchodilator FEV ≥ 70% predicted for MAD cohorts
  • Additional inclusion criteria apply

Exclusion Criteria:

  • Positive for hepatitis A, B or C, HIV or tuberculosis
  • Clinically significant abnormalities of laboratory evaluations
  • Have abnormal ECG measurements
  • Any sign of respiratory tract infection within 6 weeks of screening
  • Have a current bacterial, parasitic, fungal or viral infection
  • Uses or have used tobacco or nicotine-containing products within 6 months prior to screening
  • Additional exclusion criteria apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652038


Contacts
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Contact: Theravance Biopharma Call Center 1-855-633-8479 medinfo@theravance.com

Locations
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United Kingdom
Theravance Biopharma Investigational Site Recruiting
Manchester, England, United Kingdom, M23 9QZ
Theravance Biopharma Investigational Site Recruiting
Belfast, Northern Ireland, United Kingdom
Sponsors and Collaborators
Theravance Biopharma
Investigators
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Study Director: Medical Monitor Theravance Biopharma

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Responsible Party: Theravance Biopharma
ClinicalTrials.gov Identifier: NCT03652038     History of Changes
Other Study ID Numbers: 0175
2018-001260-38 ( EudraCT Number )
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Theravance Biopharma:
Single ascending dose
SAD
Multiple ascending dose
MAD
Phase 1
first-in-human
TD-8236
asthma

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases