HealthyPhase 1NCT01371006

Evaluation of the Effect of Multiple Dosing With BI 201335 on CYP2B6 Metabolism and Effect of Multiple Dosing With Efavirenz on the Steady-state Pharmacokinetics of BI 201335 and on CYP3A4/5 Metabolism in Healthy Volunteers

A Phase 1 study testing low dose and normal dose in people with Healthy, run by Boehringer Ingelheim at 1 site in Switzerland.

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

Obtain interaction data between BI 201335 and Efavirenz to guide dosing for each drug when administered together. To predict drug interaction between BI 201335 and Cyp 3A4 y using Midazolam as cyp 3A4 probe , Efavirenz as enzyme inducer and BI 201335 as enzyme inhibitor. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: low dose and normal dose
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 1 siteSwitzerland
Study dates: Jun 2011to Sep 2011
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 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy volunteers age 18- 55 BMI (Body Mass Index) 18.5 - 29.9

Who cannot join

Any finding on medical examination and ECG (Electrocardiography) deviating from normal
Active diseases
History of photosensitivity or rash

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

1220.20.41001 Boehringer Ingelheim Investigational Site
Basel

Other trials in Switzerland

About this study

Official title: Effect of Multiple Dosing With 240mg q 12hrs BI 201335 on the Pharmacokinetics of 50 mg Single Dose Efavirenz and Effect of Multiple Dosing With 600mg QD Efavirenz on Cyp 3A4 and the Pharmacokinetics of BI 201335 in Healthy Volunteers

Obtain interaction data between BI 201335 and Efavirenz to guide dosing for each drug when administered together.

To predict drug interaction between BI 201335 and Cyp 3A4 y using Midazolam as cyp 3A4 probe , Efavirenz as enzyme inducer and BI 201335 as enzyme inhibitor.

Conditions: Healthy
Being tested: low dose, normal dose

What participants receive

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

low doseDrug
efavirenz single dosing once daily
normal doseDrug
efavirenz once daily
low doseDrug
Efavirenz single dosing once daily

Study groups in NCT01371006
Study group	Role	What they receive
BI201335 low dose Efavirenz	Experimental	low dose Efavirenz Receives: Drug: low dose
BI201335 high dose Efavirenz	Experimental	normal dose Efavirenz Receives: Drug: low dose; Drug: normal dose

What is being measured

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

Group A - Efavirenz: Cmax
Maximum plasma concentration (Cmax) of Efavirenz calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)
Measured: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00 hours(h) after administration of Efavirenz
Group A - Efavirenz: AUC0-∞
Area under the concentration-time curve of the analyte in plasma over the time interval 0 to infinity of Efavirenz calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)
Measured: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00 h after administration of Efavirenz
Group B - Faldaprevir: Cmax,ss
Maximum plasma concentration at steady state of Faldaprevir calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)
Measured: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir
Group B - Faldaprevir: AUC0-12h,ss
Area under the concentration-time curve of Faldaprevir at steady state over the time interval 0 to 12h calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)
Measured: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir
Group B - Faldaprevir: C12,ss
Plasma concentration 12 h after dosing of Faldaprevir at steady state calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)
Measured: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir

Secondary outcomes (12)

Group A - Faldaprevir: Cmax,ss
Maximum plasma concentration of Faldaprevir on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)
Measured: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir
Group A - Faldaprevir: Tmax,ss
Time of maximum concentration of Faldaprevir on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)
Measured: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir
Group A - Faldaprevir: AUC0-12h,ss
Area under the concentration-time curve of Faldaprevir over the time interval 0-12h on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)
Measured: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir
Group A - Faldaprevir: C12,ss
Plasma concentration 12 h after dosing of Faldaprevir on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)
Measured: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir
Group A - Efavirenz: Tmax
Time of maximum concentration of Efavirenz on day 14, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)
Measured: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Efavirenz
Group B - Faldaprevir: Tmax,ss
Time of maximum concentration of Faldaprevir on Day 9 and 10 at steady state, calculated for patients in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)
Measured: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir
Group B - Midazolam: Cmax
Maximum plasma concentration of Midazolam on days 1, 9 and 18, calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)
Measured: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of Midazolam
Group B - Midazolam: Tmax
Time of maximum concentration after a single dose of Midazolam on days 1, 9 and 18, calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)
Measured: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of Midazolam
Group B - Midazolam: AUC0-∞
Area under the concentration-time curve of of Midazolam over the time interval 0 to infinity on days 1, 9 and 18, calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)
Measured: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of Midazolam
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Physical Examination and ECG
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Physical Examination and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.
Measured: From first treatment administration (Day 1) up to Day 24
Group A - Number of Participants With Drug Related Adverse Events
Number of participants with investigator-defined drug related adverse events (AE) in sequence group A. AEs occurring up to 5 days after last intake of Faldaprevir on day 19 were assigned to Efavirenz+Faldaprevir treatment.
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
Measured: From Day 1 up to 30 days after last treatment (Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24)
Group B - Number of Participants With Drug Related Adverse Events
Number of participants with investigator-defined drug related adverse events (AE) in sequence group B. AEs occurring up to 5 days after last intake of Faldaprevir were assigned to Faldaprevir+Midazolam+Efavirenz treatment.
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
Measured: From Day 1 up to 30 days after last treatment (Days 1,2,6,8,9,10,11,14,17,18,19,24)

Timeline

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

Jun 2011Sep 2011

First posted10 Jun 2011 (estimated)
Study startJun 2011
Primary completionSep 2011

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 HealthyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe 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: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01371006
Sponsor's protocol ID: 1220.20
Status last verified: Jul 2015
First submitted: 9 Jun 2011
Last updated: 3 Aug 2015
Results posted: Yes, on ClinicalTrials.gov

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?

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Multiple Dosing With 240mg q 12hrs BI 201335 on the Pharmacokinetics of 50 mg Single Dose Efavirenz and Effect of Multiple Dosing With 600mg QD Efavirenz on Cyp 3A4 and the Pharmacokinetics of BI 201335 in Healthy Volunteers
ClinicalTrials.gov ID: NCT01371006
Acronym / sponsor ID: 1220.20
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jun 2011
Primary completion: Sep 2011 (actual)
First posted: 10 Jun 2011 (estimated)
Results: Posted 3 Aug 2015

Clinical summary

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

Obtain interaction data between BI 201335 and Efavirenz to guide dosing for each drug when administered together.

To predict drug interaction between BI 201335 and Cyp 3A4 y using Midazolam as cyp 3A4 probe , Efavirenz as enzyme inducer and BI 201335 as enzyme inhibitor.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
BI201335 low dose Efavirenz	Experimental	Drug: low doselow dose Efavirenz
BI201335 high dose Efavirenz	Experimental	Drug: low dose, Drug: normal dosenormal dose Efavirenz

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Healthy volunteers age 18- 55 BMI (Body Mass Index) 18.5 - 29.9

Key exclusion criteria (3 listed)

Any finding on medical examination and ECG (Electrocardiography) deviating from normal
Active diseases
History of photosensitivity or rash

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
low doseefavirenz single dosing once daily	Drug	BI201335 high dose Efavirenz
normal doseefavirenz once daily	Drug	BI201335 high dose Efavirenz
low doseEfavirenz single dosing once daily	Drug	BI201335 low dose Efavirenz

Primary outcome

Group A - Efavirenz: Cmax
Time frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00 hours(h) after administration of Efavirenz
Maximum plasma concentration (Cmax) of Efavirenz calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)
Group A - Efavirenz: AUC0-∞
Time frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00 h after administration of Efavirenz
Area under the concentration-time curve of the analyte in plasma over the time interval 0 to infinity of Efavirenz calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)
Group B - Faldaprevir: Cmax,ss
Time frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir
Maximum plasma concentration at steady state of Faldaprevir calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)
Group B - Faldaprevir: AUC0-12h,ss
Time frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir
Area under the concentration-time curve of Faldaprevir at steady state over the time interval 0 to 12h calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)
Group B - Faldaprevir: C12,ss
Time frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir
Plasma concentration 12 h after dosing of Faldaprevir at steady state calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)

12 secondary outcomes

Group A - Faldaprevir: Cmax,ss
Time frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir
Group A - Faldaprevir: Tmax,ss
Time frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir
Group A - Faldaprevir: AUC0-12h,ss
Time frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir
Group A - Faldaprevir: C12,ss
Time frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir
Group A - Efavirenz: Tmax
Time frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Efavirenz
Group B - Faldaprevir: Tmax,ss
Time frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir
Group B - Midazolam: Cmax
Time frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of Midazolam
Group B - Midazolam: Tmax
Time frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of Midazolam
Group B - Midazolam: AUC0-∞
Time frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of Midazolam
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Physical Examination and ECG
Time frame: From first treatment administration (Day 1) up to Day 24
Group A - Number of Participants With Drug Related Adverse Events
Time frame: From Day 1 up to 30 days after last treatment (Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24)
Group B - Number of Participants With Drug Related Adverse Events
Time frame: From Day 1 up to 30 days after last treatment (Days 1,2,6,8,9,10,11,14,17,18,19,24)

Results and safety

Results posted to the registry on 3 Aug 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A: 240 mg Faldaprevir+50 mg Efavirenz	14	13
Group B: 600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam	15	15

Primary outcome: Group A - Efavirenz: Cmax

Time frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00 hours(h) after administration of Efavirenz. Geometric mean (Geometric Coefficient of Variation). Unit: nmol/L

Measure	50 mg Efavirenz n = 14	50 mg Efavirenz+240 mg Faldaprevir n = 13
Value	771.0 (29.1)	809.0 (19.9)

50 mg Efavirenz vs 50 mg Efavirenz+240 mg Faldaprevir: Geometric Mean Ratio: 105.61 (90% CI 90.81 to 122.82), ANOVA

Population analysed: all subjects entered in sequence group A of the PK set. Pharmacokinetic (PK) set: This subject set included all subjects of the treated set who provided evaluable data for at least1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations.

Primary outcome: Group A - Efavirenz: AUC0-∞

Time frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00 h after administration of Efavirenz. Geometric mean (Geometric Coefficient of Variation). Unit: nmol*h/L

Measure	50 mg Efavirenz n = 14	50 mg Efavirenz+240 mg Faldaprevir n = 13
Value	36100.0 (30.3)	40700.0 (28.8)

50 mg Efavirenz vs 50 mg Efavirenz+240 mg Faldaprevir: Geometric Mean Ratio: 116.12 (90% CI 101.87 to 132.35), ANOVA

Population analysed: all subjects entered in sequence group A of the PK set.

Primary outcome: Group B - Faldaprevir: Cmax,ss

Time frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	7.5 mg Midazolam+240 mg Faldaprevir n = 15	7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz n = 14
Value	24000.0 (76.4)	17200.0 (111)

7.5 mg Midazolam+240 mg Faldaprevir vs 7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz: Geometric Mean Ratio: 71.83 (90% CI 61.46 to 83.95), ANOVA

Population analysed: all subjects entered in sequence group B of the PK set.

Primary outcome: Group B - Faldaprevir: AUC0-12h,ss

Time frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	7.5 mg Midazolam+240 mg Faldaprevir n = 15	7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz n = 14
Value	225000.0 (91.1)	146000.0 (148)

7.5 mg Midazolam+240 mg Faldaprevir vs 7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz: Geometric Mean Ratio: 64.97 (90% CI 53.32 to 79.16), ANOVA

Population analysed: all subjects entered in sequence group B of the PK set.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A: Efavirenz	0 of 14 (0%)	3 of 14 (21.4%)	Not reported
Group A: Faldaprevir	0 of 14 (0%)	13 of 14 (92.9%)	Not reported
Group A: Faldaprevir+Efavirenz	0 of 13 (0%)	11 of 13 (84.6%)	Not reported
Group B: Midazolam	0 of 15 (0%)	1 of 15 (6.7%)	Not reported
Group B: Faldaprevir	0 of 15 (0%)	14 of 15 (93.3%)	Not reported
Group B: Faldaprevir+Midazolam	0 of 15 (0%)	6 of 15 (40%)	Not reported
Group B: Faldaprevir+Midazolam+Efavirenz	0 of 15 (0%)	15 of 15 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

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 low dose and normal dose in people with Healthy, run by Boehringer Ingelheim at 1 site in Switzerland.

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 1 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 3 Aug 2015. 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 Switzerland. 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 3 Aug 2015). 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?

Group A - Efavirenz: Cmax (time frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00 hours(h) after administration of Efavirenz). The study lists 5 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 NCT01371006.

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 3 Aug 2015.