Drug-drug InteractionPhase 1NCT03723395
A Drug-Drug Interaction Study in Healthy Volunteers of the Effects of Tucatinib
A Phase 1 study testing tucatinib, itraconazole and rifampin in people with Drug-drug Interaction, run by Seagen Inc. at 2 sites in United States.
Trial summary
This study is being done to look at how tucatinib could affect the way other drugs work. This study will look at healthy volunteers and how tucatinib affects their liver enzymes. Liver enzymes can change how drugs work in the body. There are 5 parts to this study. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug-drug Interaction
- What is being tested?
- tucatinib, itraconazole and rifampin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Sep 2018to 28 Dec 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) between 18 and 32 kg/m^2
- In good health, determined be no clinically significant findings from medical history, physical examination, and screening evaluations
- Female subjects must be of nonchildbearing potential
- Male subjects must agree to use contraception or must be surgically sterile for at least 90 days prior to enrollment
- Able to understand and sign informed consent form
Who cannot join
- Any condition affecting drug absorption (including stomach or intestinal surgery)
- Significant history of metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
- History of hypersensitivity, intolerance, or allergy to any drug compounds, food, or other substance (unless approved by Investigator)
- Participation in a clinical study involving an investigational drug within the past 30 days
- Use or intend to any prescription medications within 28 days prior to check in
- Use of tobacco- or nicotine-containing products within 28 days prior to check in
Show all 10Show fewer
- History of hyperbilirubinemia
- History of alcoholism or drug abuse within 2 years
- History of regular alcohol consumption exceeding 7 drinks/week for female subjects or 14 drinks/week for male subjects
- Positive hepatitis panel and/or positive human immunodeficiency virus (HIV) test
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Covance Clinical Research Unit
Dallas, Texas, 75247
Covance Clinical Research Unit
Daytona Beach, Florida, 32117
About this study
Official title: A Phase 1, Open-Label, Fixed-sequence, 5-part, Drug-drug Interaction Study of Tucatinib to Evaluate the Effects of CYP3A4 and CYP2C8 Inhibition and Induction on the Pharmacokinetics of Tucatinib and to Evaluate the Effects of Tucatinib on the Pharmacokinetics of Substrates of CYP3A4, CYP2C8, CYP2C9, and P-glycoprotein in Healthy Male and Female Subjects
This study is being done to look at how tucatinib could affect the way other drugs work. This study will look at healthy volunteers and how tucatinib affects their liver enzymes. Liver enzymes can change how drugs work in the body. There are 5 parts to this study. Parts A and C are looking at how the body breaks down tucatinib when there are lower levels of certain liver enzymes. Part B is looking at how the body breaks down tucatinib when there are high levels of certain liver and stomach enzymes. Parts D and E are looking at how tucatinib could change the levels of some liver and stomach enzymes in the body. This will help us know more about how tucatinib should be given to patients.
Read the detailed description
This is a fixed-sequence, drug-drug interaction study of tucatinib conducted in 5 parts in healthy subjects. Part A will evaluate the effect of the strong CYP3A4 inhibitor itraconazole on the pharmacokinetics (PK) of tucatinib. Part B will evaluate the effect of rifampin, a strong inducer of CYP3A4 and CYP2C8, on the PK of tucatinib. Part C will evaluate the effect of the strong CYP2C8 inhibitor gemfibrozil on the PK of tucatinib. Part D will evaluate the effects of tucatinib on the PK of substrate probes of the metabolizing enzymes CYP2C8 (repaglinide), CYP2C9 (tolbutamide), and CYP3A4 (midazolam). Part E will evaluate the effect of tucatinib on the PK of a substrate probe of the transporter P-gp (digoxin). Parts A, B, C, D, and E of the study are independent of one another and do not need to be conducted in a particular order.
- Conditions
- Drug-drug Interaction
- Being tested
- tucatinib, itraconazole, rifampin, gemfibrozil, repaglinide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tucatinibDrug
300mg dose, orally administered
itraconazoleDrug
200mg dose
rifampinDrug
600mg dose
gemfibrozilDrug
600mg tablets
repaglinideDrug
1mg dose
tolbutamideDrug
500mg dose
midazolamDrug
2mg dose
digoxinDrug
0.5 mg dose
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Tucatinib plus Itraconazole Receives: Drug: tucatinib; Drug: itraconazole |
| Part B | Experimental | Tucatinib plus Rifampin Receives: Drug: tucatinib; Drug: rifampin |
| Part C | Experimental | Tucatinib plus Gemfibrozil Receives: Drug: tucatinib; Drug: gemfibrozil |
| Part D | Experimental | Tucatinib plus Repaglinide plus Tolbutamide plus Midazolam Receives: Drug: tucatinib; Drug: repaglinide; Drug: tolbutamide; Drug: midazolam |
| Part E | Experimental | Tucatinib plus Digoxin Receives: Drug: tucatinib; Drug: digoxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve (AUC) from time 0 to infinity
PK parameters for tucatinib (Parts A, B, and C); repaglinide and its M4 metabolite (Part D), tolbutamide and its 4-hydroxytolbutamide metabolite (Part D), midazolam and its 1-hydroxymidazolam metabolite (Part D), and digoxin (Part E)
Measured: Up to 22 days
AUC from time 0 to the time of the last quantifiable concentration
PK parameters for tucatinib (Parts A, B, and C); repaglinide and its M4 metabolite (Part D), tolbutamide and its 4-hydroxytolbutamide metabolite (Part D), midazolam and its 1-hydroxymidazolam metabolite (Part D), and digoxin (Part E)
Measured: Up to 22 days
Percentage extrapolation in AUC
PK parameters for tucatinib (Parts A, B, and C); repaglinide and its M4 metabolite (Part D), tolbutamide and its 4-hydroxytolbutamide metabolite (Part D), midazolam and its 1-hydroxymidazolam metabolite (Part D), and digoxin (Part E)
Measured: Up to 22 days
Maximum observed concentration
PK parameters for tucatinib (Parts A, B, and C); repaglinide and its M4 metabolite (Part D), tolbutamide and its 4-hydroxytolbutamide metabolite (Part D), midazolam and its 1-hydroxymidazolam metabolite (Part D), and digoxin (Part E)
Measured: Up to 22 days
Time of maximum observed concentration
PK parameters for tucatinib (Parts A, B, and C); repaglinide and its M4 metabolite (Part D), tolbutamide and its 4-hydroxytolbutamide metabolite (Part D), midazolam and its 1-hydroxymidazolam metabolite (Part D), and digoxin (Part E)
Measured: Up to 22 days
Apparent terminal elimination half-life
PK parameters for tucatinib (Parts A, B, and C); repaglinide and its M4 metabolite (Part D), tolbutamide and its 4-hydroxytolbutamide metabolite (Part D), midazolam and its 1-hydroxymidazolam metabolite (Part D), and digoxin (Part E)
Measured: Up to 22 days
Apparent total clearance
PK parameters for tucatinib (Parts A, B, and C); repaglinide (Part D), tolbutamide (Part D), midazolam (Part D), and digoxin (Part E).
Measured: Up to 22 days
Apparent volume of distribution
PK parameters for tucatinib (Parts A, B, and C); repaglinide (Part D), tolbutamide (Part D), midazolam (Part D), and digoxin (Part E).
Measured: Up to 22 days
Metabolite-to-parent ratio based on AUC
PK parameters for M4 metabolite, 4-hydroxytolbutamide metabolite, and 1-hydroxymidazolam metabolite (Part D only)
Measured: Up to 22 days
Secondary outcomes (21)
Incidence of adverse events (AEs)
Parts A, B, C, D, and E (all)
Measured: Up to 58 days
Incidence of laboratory abnormalities
Parts A, B, C, D, and E (all)
Measured: Up to 58 days
12-lead electrocardiogram (ECG) assessment
PR, RR, QRS, and QT interval. Parts A, B, C, D, and E (all)
Measured: Up to 58 days
Vital signs measurements
Oral temperature. Parts A, B, C, D, and E (all)
Measured: Up to 58 days
Vital signs measurements
Respiratory rate. Parts A, B, C, D, and E (all)
Measured: Up to 58 days
Vital signs measurements
Blood pressure (systolic and diastolic). Parts A, B, C, D, and E (all)
Measured: Up to 58 days
Vital signs measurements
Heart rate. Parts A, B, C, D, and E (all)
Measured: Up to 58 days
Physical examinations
Incidence of AEs resulting from clinically significant findings in examination of general appearance, skin, thorax/lungs, cardiovascular system, and abdomen. Parts A, B, C, D, and E (all)
Measured: Up to 58 days
AUC within a dosing interval
PK parameters of tucatinib and ONT-993; Parts D and E only
Measured: Up to 15 days
AUC from time 0 to infinity
PK parameters of tucatinib and ONT-993; Parts D and E only
Measured: Up to 8 days
AUC from time 0 to the time of the last quantifiable concentration
PK parameters of tucatinib and ONT-993; Parts D and E only
Measured: Up to 15 days
Percentage extrapolation in AUC
PK parameters of tucatinib and ONT-993; Parts D and E only
Measured: Up to 15 days
Maximum observed concentration
PK parameters of tucatinib and ONT-993; Parts D and E only
Measured: Up to 15 days
Time of maximum observed concentration
PK parameters of tucatinib and ONT-993; Parts D and E only
Measured: Up to 15 days
Apparent terminal elimination half-life
PK parameters of tucatinib and ONT-993; Parts D and E only
Measured: Up to 15 days
Apparent total clearance
PK parameter of tucatinib; Parts D and E only
Measured: Up to 8 days
Apparent total clearance at steady state
PK parameter of tucatinib; Parts D and E only
Measured: Up to 15 days
Apparent volume of distribution
PK parameter of tucatinib; Parts D and E only
Measured: Up to 8 days
Apparent volume of distribution at steady state
PK parameter of tucatinib; Parts D and E only
Measured: Up to 15 days
Accumulation ratio
PK parameters of tucatinib and ONT-993; Parts D and E only
Measured: Up to 15 days
Metabolite-to-parent ratio based on AUC
PK parameter of ONT-993; Parts D and E only
Measured: Up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start17 Sep 2018
- Primary completion21 Dec 2018
- Study completion28 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Drug-drug InteractionStudies 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
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alex Vo, PhD, Study director, Seagen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723395
- Sponsor's protocol ID
- ONT-380-012
- Status last verified
- Dec 2019
- First submitted
- 24 Oct 2018
- Last updated
- 18 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Zhang D, Taylor A, Zhao JJ, Endres CJ, Topletz-Erickson A. Population Pharmacokinetic Analysis of Tucatinib in Healthy Participants and Patients with Breast Cancer or Colorectal Cancer. Clin Pharmacokinet. 2024 Oct;63(10):1477-1487. doi: 10.1007/s40262-024-01412-0. Epub 2024 Oct 5.
PubMed 39368039Topletz-Erickson A, Lee A, Rustia EL, Sun H, Mayor JG, Abdulrasool LI, Walker L, Endres CJ. Evaluation of Safety and Clinically Relevant Drug-Drug Interactions with Tucatinib in Healthy Volunteers. Clin Pharmacokinet. 2022 Oct;61(10):1417-1426. doi: 10.1007/s40262-022-01144-z. Epub 2022 Aug 6.
PubMed 35931943
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Fixed-sequence, 5-part, Drug-drug Interaction Study of Tucatinib to Evaluate the Effects of CYP3A4 and CYP2C8 Inhibition and Induction on the Pharmacokinetics of Tucatinib and to Evaluate the Effects of Tucatinib on the Pharmacokinetics of Substrates of CYP3A4, CYP2C8, CYP2C9, and P-glycoprotein in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT03723395
- Acronym / sponsor ID
- ONT-380-012
- Conditions
- Drug-drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 28 Dec 2018 (actual)
- First posted
- 29 Oct 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 being done to look at how tucatinib could affect the way other drugs work. This study will look at healthy volunteers and how tucatinib affects their liver enzymes. Liver enzymes can change how drugs work in the body. There are 5 parts to this study. Parts A and C are looking at how the body breaks down tucatinib when there are lower levels of certain liver enzymes. Part B is looking at how the body breaks down tucatinib when there are high levels of certain liver and stomach enzymes. Parts D and E are looking at how tucatinib could change the levels of some liver and stomach enzymes in the body. This will help us know more about how tucatinib should be given to patients.
Detailed description
This is a fixed-sequence, drug-drug interaction study of tucatinib conducted in 5 parts in healthy subjects. Part A will evaluate the effect of the strong CYP3A4 inhibitor itraconazole on the pharmacokinetics (PK) of tucatinib. Part B will evaluate the effect of rifampin, a strong inducer of CYP3A4 and CYP2C8, on the PK of tucatinib. Part C will evaluate the effect of the strong CYP2C8 inhibitor gemfibrozil on the PK of tucatinib. Part D will evaluate the effects of tucatinib on the PK of substrate probes of the metabolizing enzymes CYP2C8 (repaglinide), CYP2C9 (tolbutamide), and CYP3A4 (midazolam). Part E will evaluate the effect of tucatinib on the PK of a substrate probe of the transporter P-gp (digoxin). Parts A, B, C, D, and E of the study are independent of one another and do not need to be conducted in a particular order.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: tucatinib, Drug: itraconazoleTucatinib plus Itraconazole |
| Part B | Experimental | Drug: tucatinib, Drug: rifampinTucatinib plus Rifampin |
| Part C | Experimental | Drug: tucatinib, Drug: gemfibrozilTucatinib plus Gemfibrozil |
| Part D | Experimental | Drug: tucatinib, Drug: repaglinide, Drug: tolbutamide, Drug: midazolamTucatinib plus Repaglinide plus Tolbutamide plus Midazolam |
| Part E | Experimental | Drug: tucatinib, Drug: digoxinTucatinib plus Digoxin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Body mass index (BMI) between 18 and 32 kg/m^2
- In good health, determined be no clinically significant findings from medical history, physical examination, and screening evaluations
- Female subjects must be of nonchildbearing potential
- Male subjects must agree to use contraception or must be surgically sterile for at least 90 days prior to enrollment
- Able to understand and sign informed consent form
Key exclusion criteria (10 listed)
- Any condition affecting drug absorption (including stomach or intestinal surgery)
- Significant history of metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
- History of hypersensitivity, intolerance, or allergy to any drug compounds, food, or other substance (unless approved by Investigator)
- Participation in a clinical study involving an investigational drug within the past 30 days
- Use or intend to any prescription medications within 28 days prior to check in
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 |
|---|---|---|
| tucatinib300mg dose, orally administered | Drug | Part A, Part B, Part C, Part D, Part E |
| itraconazole200mg dose | Drug | Part A |
| rifampin600mg dose | Drug | Part B |
| gemfibrozil600mg tablets | Drug | Part C |
| repaglinide1mg dose | Drug | Part D |
| tolbutamide500mg dose | Drug | Part D |
| midazolam2mg dose | Drug | Part D |
| digoxin0.5 mg dose | Drug | Part E |
Primary outcome
Area under the concentration-time curve (AUC) from time 0 to infinity
Time frame: Up to 22 days
PK parameters for tucatinib (Parts A, B, and C); repaglinide and its M4 metabolite (Part D), tolbutamide and its 4-hydroxytolbutamide metabolite (Part D), midazolam and its 1-hydroxymidazolam metabolite (Part D), and digoxin (Part E)
AUC from time 0 to the time of the last quantifiable concentration
Time frame: Up to 22 days
PK parameters for tucatinib (Parts A, B, and C); repaglinide and its M4 metabolite (Part D), tolbutamide and its 4-hydroxytolbutamide metabolite (Part D), midazolam and its 1-hydroxymidazolam metabolite (Part D), and digoxin (Part E)
Percentage extrapolation in AUC
Time frame: Up to 22 days
PK parameters for tucatinib (Parts A, B, and C); repaglinide and its M4 metabolite (Part D), tolbutamide and its 4-hydroxytolbutamide metabolite (Part D), midazolam and its 1-hydroxymidazolam metabolite (Part D), and digoxin (Part E)
Maximum observed concentration
Time frame: Up to 22 days
PK parameters for tucatinib (Parts A, B, and C); repaglinide and its M4 metabolite (Part D), tolbutamide and its 4-hydroxytolbutamide metabolite (Part D), midazolam and its 1-hydroxymidazolam metabolite (Part D), and digoxin (Part E)
Time of maximum observed concentration
Time frame: Up to 22 days
PK parameters for tucatinib (Parts A, B, and C); repaglinide and its M4 metabolite (Part D), tolbutamide and its 4-hydroxytolbutamide metabolite (Part D), midazolam and its 1-hydroxymidazolam metabolite (Part D), and digoxin (Part E)
Apparent terminal elimination half-life
Time frame: Up to 22 days
PK parameters for tucatinib (Parts A, B, and C); repaglinide and its M4 metabolite (Part D), tolbutamide and its 4-hydroxytolbutamide metabolite (Part D), midazolam and its 1-hydroxymidazolam metabolite (Part D), and digoxin (Part E)
Apparent total clearance
Time frame: Up to 22 days
PK parameters for tucatinib (Parts A, B, and C); repaglinide (Part D), tolbutamide (Part D), midazolam (Part D), and digoxin (Part E).
Apparent volume of distribution
Time frame: Up to 22 days
PK parameters for tucatinib (Parts A, B, and C); repaglinide (Part D), tolbutamide (Part D), midazolam (Part D), and digoxin (Part E).
Metabolite-to-parent ratio based on AUC
Time frame: Up to 22 days
PK parameters for M4 metabolite, 4-hydroxytolbutamide metabolite, and 1-hydroxymidazolam metabolite (Part D only)
21 secondary outcomes
Incidence of adverse events (AEs)
Time frame: Up to 58 days
Incidence of laboratory abnormalities
Time frame: Up to 58 days
12-lead electrocardiogram (ECG) assessment
Time frame: Up to 58 days
Vital signs measurements
Time frame: Up to 58 days
Vital signs measurements
Time frame: Up to 58 days
Vital signs measurements
Time frame: Up to 58 days
Vital signs measurements
Time frame: Up to 58 days
Physical examinations
Time frame: Up to 58 days
AUC within a dosing interval
Time frame: Up to 15 days
AUC from time 0 to infinity
Time frame: Up to 8 days
AUC from time 0 to the time of the last quantifiable concentration
Time frame: Up to 15 days
Percentage extrapolation in AUC
Time frame: Up to 15 days
Maximum observed concentration
Time frame: Up to 15 days
Time of maximum observed concentration
Time frame: Up to 15 days
Apparent terminal elimination half-life
Time frame: Up to 15 days
Apparent total clearance
Time frame: Up to 8 days
Apparent total clearance at steady state
Time frame: Up to 15 days
Apparent volume of distribution
Time frame: Up to 8 days
Apparent volume of distribution at steady state
Time frame: Up to 15 days
Accumulation ratio
Time frame: Up to 15 days
Metabolite-to-parent ratio based on AUC
Time frame: Up to 15 days
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 18 Dec 2019.
- Derived from this study: PubMed 39368039Zhang D, Taylor A, Zhao JJ, Endres CJ, Topletz-Erickson A. Population Pharmacokinetic Analysis of Tucatinib in Healthy Participants and Patients with Breast Cancer or Colorectal Cancer. Clin Pharmacokinet. 2024 Oct;63(10):1477-1487. doi: 10.1007/s40262-024-01412-0. Epub 2024 Oct 5.
- Derived from this study: PubMed 35931943Topletz-Erickson A, Lee A, Rustia EL, Sun H, Mayor JG, Abdulrasool LI, Walker L, Endres CJ. Evaluation of Safety and Clinically Relevant Drug-Drug Interactions with Tucatinib in Healthy Volunteers. Clin Pharmacokinet. 2022 Oct;61(10):1417-1426. doi: 10.1007/s40262-022-01144-z. Epub 2022 Aug 6.
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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.
Alex Vo, PhD study director
Seagen Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing tucatinib, itraconazole and rifampin in people with Drug-drug Interaction, run by Seagen Inc. at 2 sites 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 5 inclusion and 10 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 18 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Area under the concentration-time curve (AUC) from time 0 to infinity (time frame: Up to 22 days). The study lists 9 primary outcomes in all. 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 NCT03723395, which also lists 2 linked publications.
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 18 Dec 2019; AzTrials last refreshed its copy on 8 Nov 2026.