PsoriasisPhase 1NCT02993471

A Study of Ixekizumab in Participants With Plaque Psoriasis

A Phase 1 study testing Drug Cocktail and Ixekizumab in people with Psoriasis, run by Eli Lilly and Company at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Psoriasis
What is being tested?: Drug Cocktail and Ixekizumab
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 3 sitesUnited States
Study dates: 22 Dec 2016to 21 Nov 2017
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males and females with chronic moderate or severe plaque psoriasis for at least 6 months who are candidates for systemic therapy or phototherapy
Men and women of childbearing potential must agree to use a reliable method of birth control and men may not donate sperm for the duration of the study. Women must test negative for pregnancy at screening and agree not to become pregnant during the study and until the first normal period following the end of the study
Have a body mass index (BMI) of 18.5 to 40.0 kilograms per square meter (kg/m²), inclusive, at screening
Have greater than or equal to (≥) 10 percent body surface area (BSA) involvement at screening and first admission to the clinical research unit (CRU)
Have both a Static Physicians Global Assessment (sPGA) score of ≥3 and Psoriasis Area Severity Index (PASI) score ≥12 at screening and first admission to the CRU

Who cannot join

Forms of psoriasis other than chronic plaque-type
Pregnant or nursing (lactating women)
History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection
Have major surgery within 8 weeks prior to first admission to the clinical research unit or during the study
Have a history of lymphoproliferative disease, or signs or symptoms of lymphoproliferative disease, or have active or history of malignant disease, or have uncontrolled cerebrocardiovascular or neuropsychiatric disease
Require treatment with the cocktail drugs or with inhibitors of cytochrome P450 (CYP) 3A, CYP2C9, CYP2D6, CYP2C19, CYP1A2, or with inducers of CYP3A or CYP1A2, or with rifampin (inducer of multiple CYPs) or with substrates of CYP3A, CYP2C9, CYP2D6, CYP2C19, or CYP1A2 with narrow therapeutic indices within 14 days prior to the first administration of the drug cocktail through the end of Week 12 assessments
Have any known allergy or hypersensitivity to any component of the study cocktail or ixekizumab
Have participated in any other study with ixekizumab, secukinumab or brodalumab, or have been prescribed ixekizumab or secukinumab

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Anaheim Clinical Trials, LLC
Anaheim, California, 92801
Avail Clinical Research LLC
DeLand, Florida, 32720
High Point Clinical Trials Center
High Point, North Carolina, 27265

Other trials in United States

About this study

Official title: Evaluation of the Effect of Ixekizumab on the Pharmacokinetics of Cytochrome P450 Substrates in Patients With Moderate-to-Severe Plaque Psoriasis

This study is known as a "drug interaction study." The purpose is to learn about how ixekizumab may affect the blood levels of a mixture of commonly used drugs (caffeine, omeprazole, warfarin, dextromethorphan, and midazolam) that are metabolized by cytochrome P450. Each participant will complete two study periods. Participants will take the mixture of commonly used drugs (plus vitamin K) by mouth on 3 occasions (prior to treatment with ixekizumab and after 1 and 12 weeks of treatment with ixekizumab). The study will last about 17 weeks, including follow-up. Screening must be completed prior to study start.

Conditions: Psoriasis
Being tested: Drug Cocktail, Ixekizumab
Medical subject headings: Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Drug CocktailDrug
Also called Caffeine + Warfarin (plus vitamin K) + Omeprazole + Dextromethorphan + Midazolam
Administered orally
IxekizumabDrug
Also called LY2439821
Administered SC

Study groups in NCT02993471
Study group	Role	What they receive
Drug Cocktail	Experimental	Drug cocktail (caffeine, warfarin [plus vitamin K], omeprazole, dextromethorphan, and midazolam) administered orally once in Period 1 (day 1). Receives: Drug: Drug Cocktail
Drug Cocktail + Ixekizumab	Experimental	Drug cocktail (caffeine, warfarin [plus vitamin K], omeprazole, dextromethorphan, and midazolam) administered orally twice in Period 2 (day 8 and day 85). Ixekizumab administered subcutaneously (SC) on multiple occasions in Period 2. Receives: Drug: Drug Cocktail; Drug: Ixekizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Cytochrome P450 (CYP450) Substrate-Midazolam
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Cytochrome P450 (CYP450) Substrate (Midazolam)
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Midazolam
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC[0-∞]) of CYP450 Substrate (Midazolam)
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Warfarin
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Warfarin)
Measured: Predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Warfarin
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC[0-∞]) of CYP450 Substrate (Warfarin)
Measured: Predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Dextromethorphan
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Dextromethorphan)
Measured: Predose, 1, 2, 4, 6, 8, 10, 24, 48, and 72 hours postdose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Dextromethorphan
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC[0-∞]) of CYP450 Substrate (Dextromethorphan)
Measured: Predose, 1, 2, 4, 6, 8, 10, 24, 48, and 72 hours postdose
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Omeprazole and Its Metabolite 5-Hydroxyomeprazole
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Omeprazole and its metabolite 5-Hydroxyomeprazole)
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Omeprazole and Its Metabolite 5-Hydroxyomeprazole
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC[0-∞]) of CYP450 Substrate (Omeprazole and its metabolite 5-Hydroxyomeprazole)
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdose
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Caffeine
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Caffeine)
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to 48 Hours (AUC[0-48h]) of CYP450 Substrate-Caffeine
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to 48 hours (AUC[0-48h]) of CYP450 Substrate (Caffeine)
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Dec 201621 Nov 2017

First posted15 Dec 2016 (estimated)
Study start22 Dec 2016
Primary completion21 Nov 2017
Study completion21 Nov 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PsoriasisStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
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: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02993471
Sponsor's protocol ID: 16126
Other IDs: I1F-MC-RHBU
Status last verified: Dec 2017
First submitted: 13 Dec 2016
Last updated: 12 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
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All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Effect of Ixekizumab on the Pharmacokinetics of Cytochrome P450 Substrates in Patients With Moderate-to-Severe Plaque Psoriasis
ClinicalTrials.gov ID: NCT02993471
Acronym / sponsor ID: 16126
Conditions: Psoriasis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 22 Dec 2016 (actual)
Primary completion: 21 Nov 2017 (actual)
Study completion: 21 Nov 2017 (actual)
First posted: 15 Dec 2016 (estimated)
Results: Posted 12 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Drug Cocktail	Experimental	Drug: Drug CocktailDrug cocktail (caffeine, warfarin [plus vitamin K], omeprazole, dextromethorphan, and midazolam) administered orally once in Period 1 (day 1).
Drug Cocktail + Ixekizumab	Experimental	Drug: Drug Cocktail, Drug: IxekizumabDrug cocktail (caffeine, warfarin [plus vitamin K], omeprazole, dextromethorphan, and midazolam) administered orally twice in Period 2 (day 8 and day 85). Ixekizumab administered subcutaneously (SC) on multiple occasions in Period 2.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Males and females with chronic moderate or severe plaque psoriasis for at least 6 months who are candidates for systemic therapy or phototherapy
Men and women of childbearing potential must agree to use a reliable method of birth control and men may not donate sperm for the duration of the study. Women must test negative for pregnancy at screening and agree not to become pregnant during the study and until the first normal period following the end of the study
Have a body mass index (BMI) of 18.5 to 40.0 kilograms per square meter (kg/m²), inclusive, at screening
Have greater than or equal to (≥) 10 percent body surface area (BSA) involvement at screening and first admission to the clinical research unit (CRU)
Have both a Static Physicians Global Assessment (sPGA) score of ≥3 and Psoriasis Area Severity Index (PASI) score ≥12 at screening and first admission to the CRU

Key exclusion criteria (8 listed)

Forms of psoriasis other than chronic plaque-type
Pregnant or nursing (lactating women)
History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection
Have major surgery within 8 weeks prior to first admission to the clinical research unit or during the study
Have a history of lymphoproliferative disease, or signs or symptoms of lymphoproliferative disease, or have active or history of malignant disease, or have uncontrolled cerebrocardiovascular or neuropsychiatric disease

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
Drug CocktailAlso: Caffeine + Warfarin (plus vitamin K) + Omeprazole + Dextromethorphan + MidazolamAdministered orally	Drug	Drug Cocktail, Drug Cocktail + Ixekizumab
IxekizumabAlso: LY2439821Administered SC	Drug	Drug Cocktail + Ixekizumab

Primary outcome

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Cytochrome P450 (CYP450) Substrate-Midazolam
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Cytochrome P450 (CYP450) Substrate (Midazolam)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Midazolam
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC[0-∞]) of CYP450 Substrate (Midazolam)
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Warfarin
Time frame: Predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Warfarin)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Warfarin
Time frame: Predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC[0-∞]) of CYP450 Substrate (Warfarin)
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Dextromethorphan
Time frame: Predose, 1, 2, 4, 6, 8, 10, 24, 48, and 72 hours postdose
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Dextromethorphan)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Dextromethorphan
Time frame: Predose, 1, 2, 4, 6, 8, 10, 24, 48, and 72 hours postdose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC[0-∞]) of CYP450 Substrate (Dextromethorphan)
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Omeprazole and Its Metabolite 5-Hydroxyomeprazole
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdose
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Omeprazole and its metabolite 5-Hydroxyomeprazole)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Omeprazole and Its Metabolite 5-Hydroxyomeprazole
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC[0-∞]) of CYP450 Substrate (Omeprazole and its metabolite 5-Hydroxyomeprazole)
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Caffeine
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdose
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Caffeine)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to 48 Hours (AUC[0-48h]) of CYP450 Substrate-Caffeine
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to 48 hours (AUC[0-48h]) of CYP450 Substrate (Caffeine)

Results and safety

Results posted to the registry on 12 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Drug Cocktail /Drug Cocktail + Ixekizumab	28	28

Primary outcome: Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Cytochrome P450 (CYP450) Substrate-Midazolam

Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram per milliliter (ng/mL)

Measure	1 mg Midazolam n = 27	160 mg Ixekizumab + 1 mg Midazolam n = 26	80 mg Ixekizumab Q2W (Once Every Two Weeks) + 1 mg Midazolam n = 25
Value	4.56 (24)	4.92 (24)	4.83 (26)

Population analysed: All enrolled participants who received at least 1 dose of study drug with evaluable PK data.

Primary outcome: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Midazolam

Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram*hour per milliliter (ng*h/mL)

Measure	1 mg Midazolam n = 27	160 mg Ixekizumab + 1 mg Midazolam n = 26	80 mg Ixekizumab Q2W + 1 mg Midazolam n = 25
Value	16.6 (28)	15.9 (27)	15.4 (34)

Population analysed: All enrolled participants who received at least 1 dose of study drug with evaluable PK data.

Primary outcome: Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Warfarin

Time frame: Predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	10 mg Warfarin n = 27	160 mg Ixekizumab + 10 mg Warfarin n = 26	80 mg Ixekizumab Q2W + 10 mg Warfarin n = 25
Value	510 (26)	525 (22)	510 (23)

Population analysed: All enrolled participants who received at least 1 dose of study drug with evaluable PK data.

Primary outcome: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Warfarin

Time frame: Predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	10 mg Warfarin n = 27	160 mg Ixekizumab + 10 mg Warfarin n = 26	80 mg Ixekizumab Q2W + 10 mg Warfarin n = 25
Value	17600 (29)	17700 (31)	16200 (29)

Population analysed: All enrolled participants who received at least 1 dose of study drug with evaluable PK data.

Adverse events

Time frame: Up To 89 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Drug Cocktail	0 of 28 (0%)	1 of 28 (3.6%)	0 of 28
Drug Cocktail + Ixekizumab	0 of 27 (0%)	7 of 27 (25.9%)	0 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Click here for more information about this study: A Study of Ixekizumab in Participants with Plaque PsoriasisLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Psoriasis

Not yet recruitingPhase 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.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

3 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 Drug Cocktail and Ixekizumab in people with Psoriasis, run by Eli Lilly and Company at 3 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 8 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 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Yes. Results are posted in the registry (first posted 12 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Cytochrome P450 (CYP450) Substrate-Midazolam (time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose). The study lists 10 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 NCT02993471.

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 12 Mar 2019.