Hepatitis CPhase 1NCT02022306
TD-6450 SAD and MAD in Healthy Subjects
A Phase 1 study testing TD-6450 in people with Hepatitis C, run by Theravance Biopharma at 1 site in United States.
Trial summary
This study consists of two parts, Parts A and B. Part A is a single ascending dose (SAD) study in healthy subjects. Part B is a multiple ascending dose (MAD) study in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- TD-6450
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Sep 2014
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is a female of non-childbearing potential or male, who is healthy, nonsmoking, and 18 to 60 years old, inclusive, at screening. Females are considered to be of non childbearing potential if they have had a hysterectomy or tubal ligation (documentation required) or are postmenopausal (amenorrheic for at least 2 years) with a follicle stimulating hormone (FSH) level >40 IU/L
- Subject has a body mass index 18 to 30 kg/m2, inclusive, and weighs at least 50 kg.
Who cannot join
- Subject has evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
- Subject has an estimated creatinine clearance of <90 mL/min at Screening or Day -1, calculated using the Cockcroft-Gault equation.
- Subject has participated in another clinical trial of an investigational drug (or medical device) within 60 days prior to Screening, or is currently participating in another trial of an investigational drug (or medical device).
Trial locations and contacts
1 site in 1 country.
United States1 site
ICON Development Solutions
San Antonio, Texas, 78209
About this study
Official title: A Double-Blinded, Randomized, Placebo-Controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of TD-6450, a NS5A Inhibitor, in Healthy Subjects
This study consists of two parts, Parts A and B. Part A is a single ascending dose (SAD) study in healthy subjects. Part B is a multiple ascending dose (MAD) study in healthy subjects.
- Conditions
- Hepatitis C
- Being tested
- TD-6450, Placebo
- Keywords
- Hepatitis C
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TD-6450Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| SAD TD-6450 | Placebo comparator | Single ascending dose (Part A) Receives: Drug: TD-6450; Drug: Placebo |
| MAD TD-6450 | Placebo comparator | Multiple ascending dose (Part B) Receives: Drug: TD-6450; Drug: Placebo |
| Food effect of TD-6450 | Active comparator | Food effect will be assessed in Part A (SAD) of this study. Receives: Drug: TD-6450 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: 28 days max
Secondary outcomes (5)
Cmax
Pharmacokinetics
Measured: 28 days max
Tmax
Pharmacokinetics
Measured: 28 days max
AUC
Pharmacokinetics
Measured: 28 days max
T1/2
Pharmacokinetics
Measured: 28 days max
Food effect on AUC value
Measure difference between fasted and fed doses
Measured: 15 days max
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startFeb 2014
- Primary completionAug 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies 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
- 111 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
- NCT02022306
- Sponsor's protocol ID
- 0094
- Status last verified
- Jan 2021
- First submitted
- 17 Dec 2013
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Carucci M, Duez J, Tarning J, Garcia-Barbazan I, Fricot-Monsinjon A, Sissoko A, Dumas L, Gamallo P, Beher B, Amireault P, Dussiot M, Dao M, Hull MV, McNamara CW, Roussel C, Ndour PA, Sanz LM, Gamo FJ, Buffet P. Safe drugs with high potential to block malaria transmission revealed by a spleen-mimetic screening. Nat Commun. 2023 Apr 7;14(1):1951. doi: 10.1038/s41467-023-37359-2.
PubMed 37029122
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-Blinded, Randomized, Placebo-Controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of TD-6450, a NS5A Inhibitor, in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02022306
- Acronym / sponsor ID
- 0094
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Theravance BiopharmaIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 27 Dec 2013 (estimated)
- 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 study consists of two parts, Parts A and B. Part A is a single ascending dose (SAD) study in healthy subjects. 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
- 3
| Arm | Type | Receives |
|---|---|---|
| SAD TD-6450 | Placebo comparator | Drug: TD-6450, Drug: PlaceboSingle ascending dose (Part A) |
| MAD TD-6450 | Placebo comparator | Drug: TD-6450, Drug: PlaceboMultiple ascending dose (Part B) |
| Food effect of TD-6450 | Active comparator | Drug: TD-6450Food effect will be assessed in Part A (SAD) of this study. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subject is a female of non-childbearing potential or male, who is healthy, nonsmoking, and 18 to 60 years old, inclusive, at screening. Females are considered to be of non childbearing potential if they have had a hysterectomy or tubal ligation (documentation required) or are postmenopausal (amenorrheic for at least 2 years) with a follicle stimulating hormone (FSH) level >40 IU/L
- Subject has a body mass index 18 to 30 kg/m2, inclusive, and weighs at least 50 kg.
Key exclusion criteria (3 listed)
- Subject has evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
- Subject has an estimated creatinine clearance of <90 mL/min at Screening or Day -1, calculated using the Cockcroft-Gault equation.
- Subject has participated in another clinical trial of an investigational drug (or medical device) within 60 days prior to Screening, or is currently participating in another trial of an investigational drug (or medical device).
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-6450 | Drug | Food effect of TD-6450, MAD TD-6450, SAD TD-6450 |
| Placebo | Drug | MAD TD-6450, SAD TD-6450 |
Primary outcome
Adverse events
Time frame: 28 days max
5 secondary outcomes
Cmax
Time frame: 28 days max
Tmax
Time frame: 28 days max
AUC
Time frame: 28 days max
T1/2
Time frame: 28 days max
Food effect on AUC value
Time frame: 15 days max
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.
- Derived from this study: PubMed 37029122Carucci M, Duez J, Tarning J, Garcia-Barbazan I, Fricot-Monsinjon A, Sissoko A, Dumas L, Gamallo P, Beher B, Amireault P, Dussiot M, Dao M, Hull MV, McNamara CW, Roussel C, Ndour PA, Sanz LM, Gamo FJ, Buffet P. Safe drugs with high potential to block malaria transmission revealed by a spleen-mimetic screening. Nat Commun. 2023 Apr 7;14(1):1951. doi: 10.1038/s41467-023-37359-2.
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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-6450 in people with Hepatitis C, 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 2 inclusion and 3 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?
Adverse events (time frame: 28 days max). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02022306, which also lists 1 linked publication.
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.