HealthyPhase 1NCT01922349

Safety, Tolerability and Pharmacokinetics of BI 113608 in Healthy Asian and Caucasian Male Volunteers

A Phase 1 study testing BI 113608 in people with Healthy, run by Boehringer Ingelheim at 1 site in South Korea.

Completed

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

Trial summary

Safety, tolerability and pharmacokinetics of single and multiple oral doses of BI 113608 in healthy Chinese, Japanese and Caucasian male volunteers. Read more about this study

Who is it for?: Ages 20 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BI 113608
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 98 participants
Where: 1 siteSouth Korea
Study dates: Aug 2013to May 2014
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 20 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

-Healthy male volunteers according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (Blood Pressure, Pulse Rate), 12-lead Electrocardiogram, clinical laboratory tests
Chinese ethnicity, Japanese ethnicity according to the following criteria Japanese; born in Japan, be a current Japanese passport holder, have lived outside of Japan <10 years, and have parents and grandparents who were all born in Japan Chinese; ethnic Chinese, born in China or ethnic Chinese born outside of China, and a descendent of 4 ethnic Chinese grandparents who were all born in China
Caucasian
Age older than 20 and younger than 45 years
Normal lung function testing
Normal peripheral oxygen saturation as determined by non-invasive pulse oxymetry

Show all 9Show fewer

Body Mass Index more than 18.5 and Body Mass Index less than 25 kg/m2 for Japanese and Chinese
Body Mass Index more than 18.5 and Body Mass Index less than 29.9 kg/m2 for Caucasians
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation.

Who cannot join

Any finding of the medical examination (including Blood Pressure, Pulse Rate and Electrocardiogram) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (including but not limited to any kind of seizures, migraine, stroke or psychiatric disorders) within the past 6 month
History of relevant orthostatic hypotension, fainting spells or blackouts.

Show all 21Show fewer

Chronic or relevant acute infections
History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
Participation in another trial with an investigational drug within two months prior to administration or during the trial
Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
Inability to refrain from smoking on trial days
Alcohol abuse (more than 20 g/day)
Drug abuse
Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
Excessive physical activities (within one week prior to administration or during the trial)
Any laboratory value outside the reference range that is of clinical relevance
Inability to comply with dietary regimen of trial site
A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms);
A history of additional risk factors for Torsades de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)

Trial locations and contacts

1 site in 1 country.

South Korea1 site

1314.9.8201 Boehringer Ingelheim Investigational Site
Seoul

Other trials in South Korea

About this study

Official title: Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses and Multiple Rising Oral Doses of BI 113608 in Healthy Male Asian and Caucasian Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups)

Safety, tolerability and pharmacokinetics of single and multiple oral doses of BI 113608 in healthy Chinese, Japanese and Caucasian male volunteers.

Conditions: Healthy
Being tested: BI 113608, Placebo

What participants receive

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

BI 113608Drug
Medium dose (Multiple dosing)
PlaceboDrug
Placebo (Multiple dosing)
BI 113608Drug
Low dose (Multiple dosing)
PlaceboDrug
Placebo (Single dosing)
BI 113608Drug
High dose (Single dosing)
BI 113608Drug
Medium dose (Single dosing)
BI 113608Drug
Low dose (Single dosing)
BI 113608Drug
High dose (Multiple dosing)

Study groups in NCT01922349
Study group	Role	What they receive
Placebo (Multiple dose)	Placebo comparator	Placebo Receives: Drug: Placebo
Dose 1, Single dose	Experimental	Low dose Receives: Drug: BI 113608
Dose 2, Single dose	Experimental	Medium dose Receives: Drug: BI 113608
Dose 3, Single dose	Experimental	High dose Receives: Drug: BI 113608
Dose 4, Multiple dose	Experimental	Low dose Receives: Drug: BI 113608
Dose 5, Multiple dose	Experimental	Medium dose Receives: Drug: BI 113608
Dose 6, Multiple dose	Experimental	High dose Receives: Drug: BI 113608
Placebo (Single dose)	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

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

Number (%) of Subjects With Drug-related Adverse Events
Percentage of subjects with drug-related adverse events (AE) in the SRD and MRD periods combined. The investigator assessed the possible causal relationship between an AE and the trial medication.
Measured: Up to 21 days (4 days for SRD period and 17 days for MRD period)

Secondary outcomes (11)

Cmax (Maximum Measured Concentration of the Analyte in Plasma)
maximum measured concentration of the analyte in plasma after a single dose of BI 113608.
Measured: 0.25 hours (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administration
Tmax (Time From Dosing to Maximum Measured Concentration in Plasma)
Time from dosing to maximum measured concentration in plasma after a single dose of BI 113608.
Measured: 0.25 hours (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administration
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after a single dose of BI 113608.
Measured: 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administration
AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma From Time 0 to Time of Last Quantifiable Data Point)
Area under the concentration-time curve of the analyte in plasma from time 0 to time of last quantifiable data point after a single dose of BI 113608.
Measured: 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administration
t1/2 (Terminal Half-life of the Analyte in Plasma After the First Dose)
Terminal half-life of the analyte in plasma after a single dose of BI 113608.
Measured: 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administration
Cmax,ss
Maximum measured concentration of the analyte in plasma at steady state
Measured: 23.92h, 71.92h, 119.92h, 167.92h, 215.92h, 227.92h, 263.92h, 275.92h, 311.92h, 312.25h, 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 348h, 360h, 384h
Tmax,ss
Time from last dosing to maximum concentration of the analyte in plasma at steady state
Measured: 23.92h, 71.92h, 119.92h, 167.92h, 215.92h, 227.92h, 263.92h, 275.92h, 311.92h, 312.25h, 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 348h, 360h, 384h
AUCtau,ss
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval tau
Measured: 23.92h, 71.92h, 119.92h, 167.92h, 215.92h, 227.92h, 263.92h, 275.92h, 311.92h, 312.25h, 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 348h, 360h, 384h
t1/2,ss
Terminal half-life of the analyte in plasma at steady state
Measured: 23.92h, 71.92h, 119.92h, 167.92h, 215.92h, 227.92h, 263.92h, 275.92h, 311.92h, 312.25h, 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 348h, 360h, 384h
RA,Cmax (Accumulation Ratio of the Analyte in Plasma at Steady State After Multiple Oral Administration Over a Uniform Dosing Interval Tau)
Accumulation ratio of the analyte in plasma at steady state after multiple oral administration over a uniform dosing interval tau, expressed as ratio of Cmax at steady state and after single dose
Measured: 0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,24h,36h,48h,~72h in SRD and ~24h,~72h,~120h,~168h,~216h,~228h,~264h,~276h,~312h,~312.25h,312.5h,312.75h,313h,313.5h,314h,314.5h,315h,316h,318h,320h,322h,324h,328h,336h,348h,360h,384h in MRD
RA,AUC (Accumulation Ratio of the Analyte in Plasma at Steady State After Multiple Dose Administration Over a Uniform Dosing Interval Tau)
Accumulation ratio of the analyte in plasma at steady state after multiple dose administration over a uniform dosing interval tau, expressed as ratio of AUC at steady state and after single dose
Measured: 0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,24h,36h,48h,~72h in SRD and ~24h,~72h,~120h,~168h,~216h,~228h,~264h,~276h,~312h,~312.25h,312.5h,312.75h,313h,313.5h,314h,314.5h,315h,316h,318h,320h,322h,324h,328h,336h,348h,360h,384h in MRD

Timeline

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

Aug 2013May 2014

First posted14 Aug 2013 (estimated)
Study startAug 2013
Primary completionMay 2014
Study completionMay 2014

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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 98 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01922349
Sponsor's protocol ID: 1314.9
Status last verified: Aug 2014
First submitted: 12 Aug 2013
Last updated: 20 Jan 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?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses and Multiple Rising Oral Doses of BI 113608 in Healthy Male Asian and Caucasian Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups)
ClinicalTrials.gov ID: NCT01922349
Acronym / sponsor ID: 1314.9
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 98 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Aug 2013
Primary completion: May 2014 (actual)
Study completion: May 2014 (actual)
First posted: 14 Aug 2013 (estimated)
Results: Posted 20 Jan 2017

Clinical summary

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

Safety, tolerability and pharmacokinetics of single and multiple oral doses of BI 113608 in healthy Chinese, Japanese and Caucasian male volunteers.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 8

Arm	Type	Receives
Placebo (Multiple dose)	Placebo comparator	Drug: PlaceboPlacebo
Dose 1, Single dose	Experimental	Drug: BI 113608Low dose
Dose 2, Single dose	Experimental	Drug: BI 113608Medium dose
Dose 3, Single dose	Experimental	Drug: BI 113608High dose
Dose 4, Multiple dose	Experimental	Drug: BI 113608Low dose
Dose 5, Multiple dose	Experimental	Drug: BI 113608Medium dose
Dose 6, Multiple dose	Experimental	Drug: BI 113608High dose
Placebo (Single dose)	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 20 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

-Healthy male volunteers according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (Blood Pressure, Pulse Rate), 12-lead Electrocardiogram, clinical laboratory tests
Chinese ethnicity, Japanese ethnicity according to the following criteria Japanese; born in Japan, be a current Japanese passport holder, have lived outside of Japan <10 years, and have parents and grandparents who were all born in Japan Chinese; ethnic Chinese, born in China or ethnic Chinese born outside of China, and a descendent of 4 ethnic Chinese grandparents who were all born in China
Caucasian
Age older than 20 and younger than 45 years
Normal lung function testing

Key exclusion criteria (21 listed)

Any finding of the medical examination (including Blood Pressure, Pulse Rate and Electrocardiogram) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (including but not limited to any kind of seizures, migraine, stroke or psychiatric disorders) within the past 6 month

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
BI 113608Medium dose (Multiple dosing)	Drug	Dose 5, Multiple dose
PlaceboPlacebo (Multiple dosing)	Drug	Placebo (Multiple dose)
BI 113608Low dose (Multiple dosing)	Drug	Dose 4, Multiple dose
PlaceboPlacebo (Single dosing)	Drug	Placebo (Single dose)
BI 113608High dose (Single dosing)	Drug	Dose 3, Single dose
BI 113608Medium dose (Single dosing)	Drug	Dose 2, Single dose
BI 113608Low dose (Single dosing)	Drug	Dose 1, Single dose
BI 113608High dose (Multiple dosing)	Drug	Dose 6, Multiple dose

Primary outcome

Number (%) of Subjects With Drug-related Adverse Events
Time frame: Up to 21 days (4 days for SRD period and 17 days for MRD period)
Percentage of subjects with drug-related adverse events (AE) in the SRD and MRD periods combined. The investigator assessed the possible causal relationship between an AE and the trial medication.

11 secondary outcomes

Cmax (Maximum Measured Concentration of the Analyte in Plasma)
Time frame: 0.25 hours (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administration
Tmax (Time From Dosing to Maximum Measured Concentration in Plasma)
Time frame: 0.25 hours (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administration
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity)
Time frame: 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administration
AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma From Time 0 to Time of Last Quantifiable Data Point)
Time frame: 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administration
t1/2 (Terminal Half-life of the Analyte in Plasma After the First Dose)
Time frame: 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administration
Cmax,ss
Time frame: 23.92h, 71.92h, 119.92h, 167.92h, 215.92h, 227.92h, 263.92h, 275.92h, 311.92h, 312.25h, 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 348h, 360h, 384h
Tmax,ss
Time frame: 23.92h, 71.92h, 119.92h, 167.92h, 215.92h, 227.92h, 263.92h, 275.92h, 311.92h, 312.25h, 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 348h, 360h, 384h
AUCtau,ss
Time frame: 23.92h, 71.92h, 119.92h, 167.92h, 215.92h, 227.92h, 263.92h, 275.92h, 311.92h, 312.25h, 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 348h, 360h, 384h
t1/2,ss
Time frame: 23.92h, 71.92h, 119.92h, 167.92h, 215.92h, 227.92h, 263.92h, 275.92h, 311.92h, 312.25h, 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 348h, 360h, 384h
RA,Cmax (Accumulation Ratio of the Analyte in Plasma at Steady State After Multiple Oral Administration Over a Uniform Dosing Interval Tau)
Time frame: 0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,24h,36h,48h,~72h in SRD and ~24h,~72h,~120h,~168h,~216h,~228h,~264h,~276h,~312h,~312.25h,312.5h,312.75h,313h,313.5h,314h,314.5h,315h,316h,318h,320h,322h,324h,328h,336h,348h,360h,384h in MRD
RA,AUC (Accumulation Ratio of the Analyte in Plasma at Steady State After Multiple Dose Administration Over a Uniform Dosing Interval Tau)
Time frame: 0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,24h,36h,48h,~72h in SRD and ~24h,~72h,~120h,~168h,~216h,~228h,~264h,~276h,~312h,~312.25h,312.5h,312.75h,313h,313.5h,314h,314.5h,315h,316h,318h,320h,322h,324h,328h,336h,348h,360h,384h in MRD

Results and safety

Results posted to the registry on 20 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	25	25
BI 113608 - 10 mg	27	27
BI 113608 - 25 mg	18	18
BI 113608 - 50 mg	27	27

Primary outcome: Number (%) of Subjects With Drug-related Adverse Events

Time frame: Up to 21 days (4 days for SRD period and 17 days for MRD period). Number. Unit: Percentage of participants

Measure	Placebo n = 25	BI 113608 - 10 mg n = 27	BI 113608 - 25 mg n = 18	BI 113608 - 50 mg n = 27
Value	28.0	51.9	33.3	92.6

Population analysed: Treated set (TS)

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 days for SRD period + 17 days for MRD period. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo- Chinese	0 of 9 (0%)	1 of 9 (11.1%)	Not reported
Placebo- Japanese	0 of 9 (0%)	3 of 9 (33.3%)	Not reported
Placebo- Caucasian	0 of 7 (0%)	5 of 7 (71.4%)	Not reported
BI 113608 - 10 mg - Chinese	0 of 9 (0%)	5 of 9 (55.6%)	Not reported
BI 113608 - 10 mg - Japanese	0 of 9 (0%)	2 of 9 (22.2%)	Not reported
BI 113608 - 10 mg - Caucasian	0 of 9 (0%)	9 of 9 (100%)	Not reported
BI 113608 - 25 mg - Chinese	0 of 9 (0%)	7 of 9 (77.8%)	Not reported
BI 113608 - 25 mg - Japanese	0 of 9 (0%)	4 of 9 (44.4%)	Not reported
BI 113608 - 50 mg - Chinese	0 of 9 (0%)	9 of 9 (100%)	Not reported
BI 113608 - 50 mg - Japanese	0 of 9 (0%)	7 of 9 (77.8%)	Not reported
BI 113608 - 50 mg - Caucasian	0 of 9 (0%)	9 of 9 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.
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 BI 113608 in people with Healthy, run by Boehringer Ingelheim at 1 site in South Korea.

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 9 inclusion and 21 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 20 Jan 2017. 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 South Korea. 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. Some participants in this study may receive a placebo. 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 20 Jan 2017). 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?

Number (%) of Subjects With Drug-related Adverse Events (time frame: Up to 21 days (4 days for SRD period and 17 days for MRD period)). 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 NCT01922349.

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 20 Jan 2017.