HealthyPhase 1NCT04044339
Single and Multiple Ascending Dose, First-in- Human Study in Healthy Subjects
A Phase 1 study testing TD-5202 in people with Healthy, run by Theravance Biopharma at 1 site in United States.
Trial 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 healthy subjects. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- TD-5202
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2019to 27 Nov 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Theravance Biopharma Investigational Site
Lincoln, Nebraska, 68502
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- TD-5202, Placebo
- Keywords
- TD-5202, 0177, single ascending dose, SAD, multiple ascending dose, MAD, first-in-human, Phase 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TD-5202Drug
Study Drug to be administered orally
PlaceboDrug
Placebo to be administered orally
| Study group | Role | What they receive |
|---|---|---|
| TD-5202 for SAD (Part A) | Experimental | 6 out of 8 subjects per cohort (up to 4 cohorts) will be randomized to receive TD-5202 Receives: Drug: TD-5202 |
| Placebo for SAD (Part A) | Placebo comparator | 2 out of 8 subjects per cohort (up to 4 cohorts) will be randomized to receive placebo Receives: Drug: Placebo |
| TD-5202 for MAD (Part B) | Experimental | 6 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive TD-5202 Receives: Drug: TD-5202 |
| Placebo for MAD (Part B) | Placebo comparator | 2 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of SAD of TD-5202 by assessing the number, severity and type of treatment emergent adverse events
Measured: 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
Measured: Day 1 through Day 17
Pharmacokinetics (PK) of TD-5202 when given as an SAD: AUC
Area under the plasma concentration-time curve (AUC)
Measured: Day 1 through Day 4
Pharmacokinetics (PK) of TD-5202 when given as a SAD: Cmax
Maximum observed concentration (Cmax)
Measured: Day 1 through Day 4
Pharmacokinetics (PK) of TD-5202 when given as a SAD: Tmax
Time to reach maximum observed concentration (Tmax)
Measured: Day 1 through Day 4
PK of TD-5202 when given as an SAD: CL/F
Oral Clearance (CL/F)
Measured: Day 1 through Day 4
PK of TD-5202 when given as an SAD: Vz/F
Terminal Phase Volume of Distribution(Vz/F)
Measured: Day 1 through Day 4
PK of TD-5202 when given as an SAD: Kel
Elimination Rate (Kel)
Measured: Day 1 through Day 4
PK of TD-5202 when given as an SAD: t 1/2
Halflife (t 1/2)
Measured: Day 1 through Day 4
PK of TD-5202 when given as an MAD: AUC
Area under the plasma concentration-time curve (AUC)
Measured: Day 1 and Day 10
PK of TD-5202 when given as an MAD: Cmax
Maximum observed concentration (Cmax)
Measured: Day 1 and Day 10
PK of TD-5202 when given as an MAD: Tmax
Time to reach maximum observed concentration (Tmax)
Measured: Day 1 and Day 10
PK of TD-5202 when given as an MAD: C trough
concentration at trough (after multiple dosing usually after reaching steady state) (C trough)
Measured: Day 2, 4, 6, 8
PK of TD-5202 when given as an MAD: Css
concentration at steady state (Css)
Measured: Day 10
PK of TD-5202 when given as an MAD: CL/Fss
Oral clearance at steady state (CL/Fss)
Measured: Day 10
PK of TD-5202 when given as an MAD: Cmin
Concentration minimum (after single dosing) (Cmin)
Measured: Day 10
PK of TD-5202 when given as an MAD: Vz/Fss
Terminal phase volume of distribution at steady state (Vz/Fss)
Measured: Day 10
PK of TD-5202 when given as an MAD: Kel
Elimination Rate (Kel)
Measured: Day 10
PK of TD-5202 when given as an MAD: t 1/2
Halflife (t 1/2)
Measured: Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start8 Aug 2019
- Primary completion27 Nov 2019
- Study completion27 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theravance Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Theravance Biopharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044339
- Sponsor's protocol ID
- 0177
- Status last verified
- Jan 2021
- First submitted
- 1 Aug 2019
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04044339
- Acronym / sponsor ID
- 0177
- Conditions
- Healthy
- Keywords
- TD-5202, 0177, single ascending dose, SAD, multiple ascending dose, MAD, first-in-human, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Theravance BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 27 Nov 2019 (actual)
- Study completion
- 27 Nov 2019 (actual)
- First posted
- 5 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TD-5202 for SAD (Part A) | Experimental | Drug: TD-52026 out of 8 subjects per cohort (up to 4 cohorts) will be randomized to receive TD-5202 |
| Placebo for SAD (Part A) | Placebo comparator | Drug: Placebo2 out of 8 subjects per cohort (up to 4 cohorts) will be randomized to receive placebo |
| TD-5202 for MAD (Part B) | Experimental | Drug: TD-52026 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive TD-5202 |
| Placebo for MAD (Part B) | Placebo comparator | Drug: Placebo2 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive placebo. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TD-5202Study Drug to be administered orally | Drug | TD-5202 for MAD (Part B), TD-5202 for SAD (Part A) |
| PlaceboPlacebo to be administered orally | Drug | Placebo for MAD (Part B), Placebo for SAD (Part A) |
Primary outcome
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
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
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)
Pharmacokinetics (PK) of TD-5202 when given as a SAD: Cmax
Time frame: Day 1 through Day 4
Maximum observed concentration (Cmax)
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)
PK of TD-5202 when given as an SAD: CL/F
Time frame: Day 1 through Day 4
Oral Clearance (CL/F)
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)
PK of TD-5202 when given as an SAD: Kel
Time frame: Day 1 through Day 4
Elimination Rate (Kel)
PK of TD-5202 when given as an SAD: t 1/2
Time frame: Day 1 through Day 4
Halflife (t 1/2)
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)
PK of TD-5202 when given as an MAD: Cmax
Time frame: Day 1 and Day 10
Maximum observed concentration (Cmax)
PK of TD-5202 when given as an MAD: Tmax
Time frame: Day 1 and Day 10
Time to reach maximum observed concentration (Tmax)
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)
PK of TD-5202 when given as an MAD: Css
Time frame: Day 10
concentration at steady state (Css)
PK of TD-5202 when given as an MAD: CL/Fss
Time frame: Day 10
Oral clearance at steady state (CL/Fss)
PK of TD-5202 when given as an MAD: Cmin
Time frame: Day 10
Concentration minimum (after single dosing) (Cmin)
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)
PK of TD-5202 when given as an MAD: Kel
Time frame: Day 10
Elimination Rate (Kel)
PK of TD-5202 when given as an MAD: t 1/2
Time frame: Day 10
Halflife (t 1/2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Individual participant dataSharing planned: No. Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Theravance Biopharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TD-5202 in people with Healthy, run by Theravance Biopharma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2021.