Healthy VolunteersPhase 1NCT01249131

A Study of Relative Bioavailability and Food Effect Study of Cobimetinib in Healthy Participants

A Phase 1 study testing Cobimetinib in people with Healthy Volunteers, run by Genentech, Inc..

Completed

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

Trial summary

This study will be an open-label, randomized, 3-way, 6-sequence crossover study in healthy participants for determining the relative bioavailability of the tablet formulation to the capsule formulation and the effect of food on the relative bioavailability of the tablet formulation. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Cobimetinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: No sites listed yet
Study dates: 1 Dec 2010to 10 Jan 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

Within body mass index range 18.5 to 29.9 kilograms per meter square (kg/m^2)
In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG) and vital signs
Clinical laboratory evaluations within the reference range for the test laboratory
Negative test for selected drugs of abuse at Screening and at each Check-in
Negative hepatitis panel and anti-hepatitis C virus and negative human immunodeficiency virus (HIV) antibody screens
Healthy males and females of non-child-bearing potential or who agree to use effective contraception

Who cannot join

Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs except that appendectomy, hernia repair, and cholecystectomy will be allowed
History or presence of an abnormal ECG
History of alcoholism or drug addiction prior to study start
Use of any tobacco-containing or nicotine-containing products prior to study start

Show all 12Show fewer

Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 28 days or 5 half-lives, whichever is longer, prior to study start
Use of any prescription medications/products, including proton pump inhibitors, within 14 days prior to study start
Poor peripheral venous access
Any acute or chronic condition that would limit the participant's ability to complete and/or participate in this clinical study
Female participant is pregnant, lactating, or breastfeeding
Predisposing factors to retinal vein occlusion (RVO)

About this study

Official title: A Phase I, Single-Dose, Randomized, Cross-Over, Relative Bioavailability, and Food Effect Study of GDC-0973 in Healthy Subjects

Conditions: Healthy Volunteers
Being tested: Cobimetinib

What participants receive

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

CobimetinibDrug
Also called GDC-0973, XL518
Cobimetinib 20 mg will be given orally as tablet formulation in fasted or fed state, or as capsule formulation in fasted state.

Study groups in NCT01249131
Study group	Role	What they receive
Treatment A first, then Treatment B, followed by Treatment C	Experimental	Treatment A: One 20-mg tablet of cobimetinib will be administered orally with 240 milliliter (mL) room temperature water after at least an 8-hour fast, in first intervention period. Treatment B: Four 5-mg capsules of cobimetinib will be administered orally with 240 mL room temperature water after at least an 8-hour fast, in second intervention period. Treatment C: One 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water within 30 minutes of eating a standard Food and Drug Administration (FDA) high-fat meal, in third intervention period. The washout period between each period will be a minimum of 10 days. Receives: Drug: Cobimetinib
Treatment A first, then Treatment C, followed by Treatment B	Experimental	Treatment A: One 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water after at least an 8-hour fast, in first intervention period. Treatment C: One 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in second intervention period. Treatment B: Four 5-mg capsules of cobimetinib administered will be orally with 240 mL room temperature water after at least an 8-hour fast, in third intervention period. Receives: Drug: Cobimetinib
Treatment B first, then Treatment A, followed by Treatment C	Experimental	Treatment B: Four 5-mg capsules of cobimetinib will be administered orally with 240 mL room temperature water after at least an 8-hour fast, in first intervention period. Treatment A: One 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water after at least an 8-hour fast, in second intervention period. Treatment C: One 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in third intervention period. Receives: Drug: Cobimetinib
Treatment B first, then Treatment C, followed by Treatment A	Experimental	Treatment B: Four 5-mg capsules of cobimetinib will be administered orally with 240 mL room temperature water after at least an 8-hour fast, in first intervention period. Treatment C: One 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in second intervention period. Treatment A: One 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water after at least an 8-hour fast, in third intervention period. Receives: Drug: Cobimetinib
Treatment C first, then Treatment A, followed by Treatment B	Experimental	Treatment C: One 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in first intervention period. Treatment A: One 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water after at least an 8-hour fast, in second intervention period. Treatment B: Four 5-mg capsules of cobimetinib will be administered orally with 240 mL room temperature water after at least an 8-hour fast, in third intervention period. Receives: Drug: Cobimetinib
Treatment C first, then Treatment B, followed by Treatment A	Experimental	Treatment C: One 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in first intervention period. Treatment B: Four 5-mg capsules of cobimetinib will be administered orally with 240 mL room temperature water after at least an 8-hour fast, in second intervention period. Treatment A: One 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water after at least an 8-hour fast, in third intervention period. Receives: Drug: Cobimetinib

What is being measured

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

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).
Measured: Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose
Maximum Observed Plasma Concentration (Cmax)
Measured: Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose
Minimum Observed Plasma Concentration (Cmin)
Measured: Day 1 at 0 hour (predose)
Apparent Oral Clearance (CL/F)
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Measured: Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose
Apparent Volume of Distribution (V/F)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Measured: Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose

Timeline

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

1 Dec 201010 Jan 2011

First posted29 Nov 2010 (estimated)
Study start1 Dec 2010
Primary completion10 Jan 2011
Study completion10 Jan 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 Healthy VolunteersStudies of the same condition, open and under way.
More trials run by Genentech, Inc.The 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: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01249131
Sponsor's protocol ID: MEK4953g
Status last verified: Jun 2017
First submitted: 24 Nov 2010
Last updated: 15 Aug 2017
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?

Official record

Not yet recruitingPhase 1
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Healthy Participants
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
Active, not recruitingPhase 1
A Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283
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RecruitingPhase 4
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All Healthy Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Single-Dose, Randomized, Cross-Over, Relative Bioavailability, and Food Effect Study of GDC-0973 in Healthy Subjects
ClinicalTrials.gov ID: NCT01249131
Acronym / sponsor ID: MEK4953g
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Genentech, Inc.Industry (pharma, biotech, devices)
Study start: 1 Dec 2010 (actual)
Primary completion: 10 Jan 2011 (actual)
Study completion: 10 Jan 2011 (actual)
First posted: 29 Nov 2010 (estimated)
Results: Posted 18 Jul 2016

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: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Treatment A first, then Treatment B, followed by Treatment C	Experimental	Drug: CobimetinibTreatment A: One 20-mg tablet of cobimetinib will be administered orally with 240 milliliter (mL) room temperature water after at least an 8-hour fast, in first intervention period. Treatment B: Four 5-mg capsules of cobimetinib will be administered orally with 240 mL room temperature water after at least an 8-hour fast, in second intervention period. Treatment C: One 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water within 30 minutes of eating a standard Food and Drug Administration (FDA) high-fat meal, in third intervention period. The washout period between each period will be a minimum of 10 days.
Treatment A first, then Treatment C, followed by Treatment B	Experimental	Drug: CobimetinibTreatment A: One 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water after at least an 8-hour fast, in first intervention period. Treatment C: One 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in second intervention period. Treatment B: Four 5-mg capsules of cobimetinib administered will be orally with 240 mL room temperature water after at least an 8-hour fast, in third intervention period.
Treatment B first, then Treatment A, followed by Treatment C	Experimental	Drug: CobimetinibTreatment B: Four 5-mg capsules of cobimetinib will be administered orally with 240 mL room temperature water after at least an 8-hour fast, in first intervention period. Treatment A: One 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water after at least an 8-hour fast, in second intervention period. Treatment C: One 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in third intervention period.
Treatment B first, then Treatment C, followed by Treatment A	Experimental	Drug: CobimetinibTreatment B: Four 5-mg capsules of cobimetinib will be administered orally with 240 mL room temperature water after at least an 8-hour fast, in first intervention period. Treatment C: One 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in second intervention period. Treatment A: One 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water after at least an 8-hour fast, in third intervention period.
Treatment C first, then Treatment A, followed by Treatment B	Experimental	Drug: CobimetinibTreatment C: One 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in first intervention period. Treatment A: One 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water after at least an 8-hour fast, in second intervention period. Treatment B: Four 5-mg capsules of cobimetinib will be administered orally with 240 mL room temperature water after at least an 8-hour fast, in third intervention period.
Treatment C first, then Treatment B, followed by Treatment A	Experimental	Drug: CobimetinibTreatment C: One 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in first intervention period. Treatment B: Four 5-mg capsules of cobimetinib will be administered orally with 240 mL room temperature water after at least an 8-hour fast, in second intervention period. Treatment A: One 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water after at least an 8-hour fast, in third intervention period.

Who may qualify

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

Key inclusion criteria (6 listed)

Within body mass index range 18.5 to 29.9 kilograms per meter square (kg/m^2)
In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG) and vital signs
Clinical laboratory evaluations within the reference range for the test laboratory
Negative test for selected drugs of abuse at Screening and at each Check-in
Negative hepatitis panel and anti-hepatitis C virus and negative human immunodeficiency virus (HIV) antibody screens

Key exclusion criteria (12 listed)

Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs except that appendectomy, hernia repair, and cholecystectomy will be allowed
History or presence of an abnormal ECG
History of alcoholism or drug addiction prior to study start

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
CobimetinibAlso: GDC-0973, XL518Cobimetinib 20 mg will be given orally as tablet formulation in fasted or fed state, or as capsule formulation in fasted state.	Drug	Treatment A first, then Treatment B, followed by Treatment C, Treatment A first, then Treatment C, followed by Treatment B, Treatment B first, then Treatment A, followed by Treatment C, Treatment B first, then Treatment C, followed by Treatment A, Treatment C first, then Treatment A, followed by Treatment B, Treatment C first, then Treatment B, followed by Treatment A

Primary outcome

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
Time frame: Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).
Maximum Observed Plasma Concentration (Cmax)
Time frame: Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose
Minimum Observed Plasma Concentration (Cmin)
Time frame: Day 1 at 0 hour (predose)
Apparent Oral Clearance (CL/F)
Time frame: Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Apparent Volume of Distribution (V/F)
Time frame: Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.

Results and safety

Results posted to the registry on 18 Jul 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment A First, Then Treatment B, Followed by Treatment C	3	3
Treatment A First, Then Treatment C, Followed by Treatment B	3	3
Treatment B First, Then Treatment A, Followed by Treatment C	4	4
Treatment B First, Then Treatment C, Followed by Treatment A	3	3
Treatment C First, Then Treatment A, Followed by Treatment B	3	3
Treatment C First, Then Treatment B, Followed by Treatment A	4	4

Primary outcome: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)

Time frame: Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms*hours/milliliter (ng*hr/mL)

Measure	Cobimetinib One 20 mg Tablet [Fasted] n = 19	Cobimetinib Four 5 mg Capsules [Fasted] n = 18	Cobimetinib One 20 mg Tablet [Fed] n = 20
Value	780 (34.7)	717 (45.1)	858 (42.4)

Cobimetinib One 20 mg Tablet [Fasted] vs Cobimetinib Four 5 mg Capsules [Fasted]: Ratio of Least Squares (LS) Means (in %): 94.7 (90% CI 83.9 to 107)
Cobimetinib One 20 mg Tablet [Fasted] vs Cobimetinib One 20 mg Tablet [Fed]: Ratio of LS Means (in %): 110 (90% CI 98.2 to 124)

Population analysed: Pharmacokinetic parameters populations included all enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome.

Primary outcome: Maximum Observed Plasma Concentration (Cmax)

Time frame: Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms per milliliter (ng/mL)

Measure	Cobimetinib One 20 mg Tablet [Fasted] n = 19	Cobimetinib Four 5 mg Capsules [Fasted] n = 18	Cobimetinib One 20 mg Tablet [Fed] n = 20
Value	16.0 (33.5)	14.9 (45.9)	17.2 (43.1)

Cobimetinib One 20 mg Tablet [Fasted] vs Cobimetinib Four 5 mg Capsules [Fasted]: Ratio of LS Means (in %): 96.9 (90% CI 84.2 to 111)
Cobimetinib One 20 mg Tablet [Fasted] vs Cobimetinib One 20 mg Tablet [Fed]: Ratio of LS Means (in %): 107 (90% CI 93.8 to 123)

Population analysed: Pharmacokinetic parameters populations included all enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome.

Primary outcome: Minimum Observed Plasma Concentration (Cmin)

Time frame: Day 1 at 0 hour (predose). Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Cobimetinib One 20 mg Tablet [Fasted] n = 5	Cobimetinib Four 5 mg Capsules [Fasted] n = 7	Cobimetinib One 20 mg Tablet [Fed] n = 5
Value	0.307 (46.6)	0.36 (56.6)	0.361 (60.3)

Population analysed: Pharmacokinetic parameters populations included all enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome.

Primary outcome: Apparent Oral Clearance (CL/F)

Time frame: Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: Liters per hour (L/hr)

Measure	Cobimetinib One 20 mg Tablet [Fasted] n = 19	Cobimetinib Four 5 mg Capsules [Fasted] n = 18	Cobimetinib One 20 mg Tablet [Fed] n = 20
Value	25.6 (34.7)	25.2 (45.1)	23.3 (42.4)

Population analysed: Pharmacokinetic parameters populations included all enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome.

Adverse events

Time frame: Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cobimetinib One 20 mg Tablet [Fasted]	0 of 19 (0%)	6 of 19 (31.6%)	Not reported
Cobimetinib Four 5 mg Capsules [Fasted]	0 of 19 (0%)	9 of 19 (47.4%)	Not reported
Cobimetinib One 20 mg Tablet [Fed]	0 of 20 (0%)	8 of 20 (40%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Isabelle Rooney, M.D., PhD study director

Genentech, Inc.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cobimetinib in people with Healthy Volunteers, run by Genentech, Inc..

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 6 inclusion and 12 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 15 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

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 18 Jul 2016). 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?

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) (time frame: Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose). 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 NCT01249131.

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 15 Aug 2017.