Single and Multiple Ascending Dose, First-in- Human Study in Healthy Subjects

January 12, 2021 updated by: Theravance Biopharma

A Double-blind, Randomized, Placebo-controlled, Sponsor-open, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TD-5202 in Healthy Subjects

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 healthy subjects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Lincoln, Nebraska, United States, 68502
        • Theravance Biopharma Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, 19 - 55 years old
  • Willing and able to give informed consent and comply with the study
  • Medically healthy with no clinically significant medical history
  • 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
  • Males must use acceptable contraception
  • 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 or vital sign measurements
  • Any acute illness at time 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 inclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TD-5202 for SAD (Part A)
6 out of 8 subjects per cohort (up to 4 cohorts) will be randomized to receive TD-5202
Drug: TD-5202
Study Drug to be administered orally
Placebo Comparator: Placebo for SAD (Part A)
2 out of 8 subjects per cohort (up to 4 cohorts) will be randomized to receive placebo
Drug: Placebo
Placebo to be administered orally
Experimental: TD-5202 for MAD (Part B)
6 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive TD-5202
Drug: TD-5202
Study Drug to be administered orally
Placebo Comparator: Placebo for MAD (Part B)
2 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive placebo.
Drug: Placebo
Placebo to be administered orally

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To assess the safety and tolerability of SAD of TD-5202 by assessing the number, severity and type of treatment emergent adverse events
Time Frame: Day 1 through Day 8
Day 1 through Day 8
To assess the safety and tolerability of MAD of TD-5202 by assessing the number, severity and type of treatment emergent adverse events
Time Frame: Day 1 through Day 17
Day 1 through Day 17
Pharmacokinetics (PK) of TD-5202 when given as an SAD: AUC
Time Frame: Day 1 through Day 4
Area under the plasma concentration-time curve (AUC)
Day 1 through Day 4
Pharmacokinetics (PK) of TD-5202 when given as a SAD: Cmax
Time Frame: Day 1 through Day 4
Maximum observed concentration (Cmax)
Day 1 through Day 4
Pharmacokinetics (PK) of TD-5202 when given as a SAD: Tmax
Time Frame: Day 1 through Day 4
Time to reach maximum observed concentration (Tmax)
Day 1 through Day 4
PK of TD-5202 when given as an SAD: CL/F
Time Frame: Day 1 through Day 4
Oral Clearance (CL/F)
Day 1 through Day 4
PK of TD-5202 when given as an SAD: Vz/F
Time Frame: Day 1 through Day 4
Terminal Phase Volume of Distribution(Vz/F)
Day 1 through Day 4
PK of TD-5202 when given as an SAD: Kel
Time Frame: Day 1 through Day 4
Elimination Rate (Kel)
Day 1 through Day 4
PK of TD-5202 when given as an SAD: t 1/2
Time Frame: Day 1 through Day 4
Halflife (t 1/2)
Day 1 through Day 4
PK of TD-5202 when given as an MAD: AUC
Time Frame: Day 1 and Day 10
Area under the plasma concentration-time curve (AUC)
Day 1 and Day 10
PK of TD-5202 when given as an MAD: Cmax
Time Frame: Day 1 and Day 10
Maximum observed concentration (Cmax)
Day 1 and Day 10
PK of TD-5202 when given as an MAD: Tmax
Time Frame: Day 1 and Day 10
Time to reach maximum observed concentration (Tmax)
Day 1 and Day 10
PK of TD-5202 when given as an MAD: C trough
Time Frame: Day 2, 4, 6, 8
concentration at trough (after multiple dosing usually after reaching steady state) (C trough)
Day 2, 4, 6, 8
PK of TD-5202 when given as an MAD: Css
Time Frame: Day 10
concentration at steady state (Css)
Day 10
PK of TD-5202 when given as an MAD: CL/Fss
Time Frame: Day 10
Oral clearance at steady state (CL/Fss)
Day 10
PK of TD-5202 when given as an MAD: Cmin
Time Frame: Day 10
Concentration minimum (after single dosing) (Cmin)
Day 10
PK of TD-5202 when given as an MAD: Vz/Fss
Time Frame: Day 10
Terminal phase volume of distribution at steady state (Vz/Fss)
Day 10
PK of TD-5202 when given as an MAD: Kel
Time Frame: Day 10
Elimination Rate (Kel)
Day 10
PK of TD-5202 when given as an MAD: t 1/2
Time Frame: Day 10
Halflife (t 1/2)
Day 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Theravance Biopharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 8, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 27, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 27, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0177

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

Drug and device information, study documents

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.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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