Drug Drug Interaction (DDI)Phase 1NCT03432793
Drug-Drug Interaction (DDI) Study for TD-9855
A Phase 1 study testing TD-9855, Fluvoxamine and Itraconazole in people with Drug Drug Interaction (DDI), run by Theravance Biopharma at 1 site in United States.
Trial summary
This study is designed to assess the effect of fluvoxamine, itraconazole and smoking on the PK disposition of multiple doses TD-9855 in healthy male subjects. The study will also assess the relationship between caffeine PK and TD-9855 PK disposition in healthy male smokers and non-smokers. Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Drug Drug Interaction (DDI)
- What is being tested?
- TD-9855, Fluvoxamine and Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2018to 21 Apr 2018
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing and able to give written, signed informed consent
- Male subjects 19 to 55 years of age (inclusive)
- Body mass index 19 to 32 kg/m2 (inclusive), and weigh at least 55 kg
- No clinically important abnormal physical findings as determined by the Principal Investigator (PI) at the screening and Day -1 examinations
- Negative for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) antibody at screening.
- No clinically important laboratory abnormalities as determined by the PI
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- Ability to communicate effectively with the Investigator and to comply with all study requirements, restrictions, and direction of the clinic staff
- Male subjects must abstain from sexual intercourse or use a highly effective method of birth control
- Male smokers: Subjects who self-report to have smoked > 9 cigarettes per day for at least 6 month prior to screening as confirmed by urine cotinine test at screening and Day -1.
- Male smokers: Subjects must be willing to continue consistent use of their tobacco products throughout the study.
- Additional inclusion criteria apply
Who cannot join
- Positive for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) antibody at screening.
- History or presence of clinically significant respiratory, gastrointestinal, renal, hepatic, hematologic, neurologic (including history of seizure and insomnia), cardiovascular (including postural orthostatic hypotension or tachycardia), psychiatric (including depression and known addictive disorders), musculoskeletal, genitourinary (including urinary retention), immunologic, or dermatologic disorder.
- Any other condition that, in the opinion of the PI, would confound or interfere with study participation; evaluation of safety, tolerability, or PK of the investigational drug; or prevent compliance with the study protocol
- Any history of suicide attempts/ideation or current suicidal ideation.
- Have participated in another clinical trial of an investigational drug (or medical device) within 30 days (or 5 half-lives of the investigational drug if longer than 30 days) prior to Screening, or are currently participating in another trial of an investigational drug (or medical device), or intending to participate in another trial of an investigational drug (or medical device) before completion of all scheduled safety evaluations in this trial
- Additional inclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Fixed-Sequence, Open-Label Drug-Drug Interaction Study to Assess the Effect of Fluvoxamine (CYP1A2 Inhibitor), Cigarette Smoking (CYP1A2 Inducer) and Itraconazole (CYP3A4 Inhibitor) on the Pharmacokinetics of TD-9855 in Healthy Subjects
This study is designed to assess the effect of fluvoxamine, itraconazole and smoking on the PK disposition of multiple doses TD-9855 in healthy male subjects. The study will also assess the relationship between caffeine PK and TD-9855 PK disposition in healthy male smokers and non-smokers.
- Conditions
- Drug Drug Interaction (DDI)
- Being tested
- TD-9855, Fluvoxamine, Itraconazole, Caffeine
- Keywords
- DDI, Itraconazole, Fluvoxamine, TD-9855, Smoking, Caffeine, CYP1A2, CYP3A4
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TD-9855Drug
oral tablet, QD
FluvoxamineDrug
oral tablet, QD
ItraconazoleDrug
oral tablet solution, QD
CaffeineDrug
oral solution, single dose
| Study group | Role | What they receive |
|---|---|---|
| TD-9855 + Fluvoxamine + Caffeine | Experimental | Male smokers will receive TD-9855, fluvoxamine, and caffeine Receives: Drug: TD-9855; Drug: Fluvoxamine; Drug: Caffeine |
| TD-9855 + Itraconazole + Caffeine | Experimental | Male non-smokers will receive TD-9855, itraconazole, and caffeine Receives: Drug: TD-9855; Drug: Itraconazole; Drug: Caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in TD-9855 plasma exposure when administered with itraconazole or fluvoxamine
Measured: Day 9 and Day 24
Secondary outcomes (1)
Correlation between caffeine PK disposition and TD-9855 plasma exposure
Correlation co-efficient will be calculated between caffeine/paraxanthine ratio at 4hr after caffeine dose and TD-9855 plasma AUC on Day 9 and Day 24.
Measured: Day 9 and Day 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start28 Feb 2018
- Primary completion21 Apr 2018
- Study completion21 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Drug Interaction (DDI)Studies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 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
- NCT03432793
- Sponsor's protocol ID
- 0172
- Status last verified
- Jan 2021
- First submitted
- 2 Feb 2018
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 Phase 1, Fixed-Sequence, Open-Label Drug-Drug Interaction Study to Assess the Effect of Fluvoxamine (CYP1A2 Inhibitor), Cigarette Smoking (CYP1A2 Inducer) and Itraconazole (CYP3A4 Inhibitor) on the Pharmacokinetics of TD-9855 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03432793
- Acronym / sponsor ID
- 0172
- Conditions
- Drug Drug Interaction (DDI)
- Keywords
- DDI, Itraconazole, Fluvoxamine, TD-9855, Smoking, Caffeine, CYP1A2, CYP3A4
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Theravance BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 21 Apr 2018 (actual)
- Study completion
- 21 Apr 2018 (actual)
- First posted
- 14 Feb 2018 (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 study is designed to assess the effect of fluvoxamine, itraconazole and smoking on the PK disposition of multiple doses TD-9855 in healthy male subjects. The study will also assess the relationship between caffeine PK and TD-9855 PK disposition in healthy male smokers and non-smokers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TD-9855 + Fluvoxamine + Caffeine | Experimental | Drug: TD-9855, Drug: Fluvoxamine, Drug: CaffeineMale smokers will receive TD-9855, fluvoxamine, and caffeine |
| TD-9855 + Itraconazole + Caffeine | Experimental | Drug: TD-9855, Drug: Itraconazole, Drug: CaffeineMale non-smokers will receive TD-9855, itraconazole, and caffeine |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Willing and able to give written, signed informed consent
- Male subjects 19 to 55 years of age (inclusive)
- Body mass index 19 to 32 kg/m2 (inclusive), and weigh at least 55 kg
- No clinically important abnormal physical findings as determined by the Principal Investigator (PI) at the screening and Day -1 examinations
- Negative for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) antibody at screening.
Key exclusion criteria (6 listed)
- Positive for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) antibody at screening.
- History or presence of clinically significant respiratory, gastrointestinal, renal, hepatic, hematologic, neurologic (including history of seizure and insomnia), cardiovascular (including postural orthostatic hypotension or tachycardia), psychiatric (including depression and known addictive disorders), musculoskeletal, genitourinary (including urinary retention), immunologic, or dermatologic disorder.
- Any other condition that, in the opinion of the PI, would confound or interfere with study participation; evaluation of safety, tolerability, or PK of the investigational drug; or prevent compliance with the study protocol
- Any history of suicide attempts/ideation or current suicidal ideation.
- Have participated in another clinical trial of an investigational drug (or medical device) within 30 days (or 5 half-lives of the investigational drug if longer than 30 days) prior to Screening, or are currently participating in another trial of an investigational drug (or medical device), or intending to participate in another trial of an investigational drug (or medical device) before completion of all scheduled safety evaluations in this trial
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-9855oral tablet, QD | Drug | TD-9855 + Fluvoxamine + Caffeine, TD-9855 + Itraconazole + Caffeine |
| Fluvoxamineoral tablet, QD | Drug | TD-9855 + Fluvoxamine + Caffeine |
| Itraconazoleoral tablet solution, QD | Drug | TD-9855 + Itraconazole + Caffeine |
| Caffeineoral solution, single dose | Drug | TD-9855 + Fluvoxamine + Caffeine, TD-9855 + Itraconazole + Caffeine |
Primary outcome
Change in TD-9855 plasma exposure when administered with itraconazole or fluvoxamine
Time frame: Day 9 and Day 24
1 secondary outcome
Correlation between caffeine PK disposition and TD-9855 plasma exposure
Time frame: Day 9 and Day 24
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-9855, Fluvoxamine and Itraconazole in people with Drug Drug Interaction (DDI), 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 11 inclusion and 6 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. 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?
Change in TD-9855 plasma exposure when administered with itraconazole or fluvoxamine (time frame: Day 9 and Day 24). 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.