HealthyPhase 1NCT02342717

Relative Bioavailability of a Single Oral Dose of BI 425809 When Administered Alone or in Combination With Multiple Oral Doses of Itraconazole in Healthy Male Subjects

A Phase 1 study testing BI 425809 and Itraconazole in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

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

To investigate whether and to what extent co-administration of multiple doses of itraconazole affect single dose pharmacokinetics of BI 425809 in healthy male subjects Read more about this study

Who is it for?: Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BI 425809 and Itraconazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteGermany
Study dates: 29 Jan 2015to 24 Mar 2015
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 50 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
Age of 18 to 50 years (incl.)
Body mass index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Who cannot join

Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease judged as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)

Show all 27Show fewer

Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
History of relevant orthostatic hypotension, fainting spells, or blackouts
Chronic or relevant acute infections
History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
Intake of drugs with a long half-life (more than 24 h) within 30 days or less than 10 halflives of the respective drug prior to administration of trial medication
Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial or that might prolong the QT/QTc interval
Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication
Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
Inability to refrain from smoking on specified trial days
Alcohol abuse (consumption of more than 30 g per day)
Drug abuse or positive drug screening
Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial
Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial
Inability to comply with dietary regimen of trial site
A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms) or any other relevant ECG finding at screening
A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)
Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
Male subjects who do not agree to minimize the risk of female partners becoming pregnant from the first dosing day until two month after the trial completion. Acceptable methods of contraception comprise barrier contraception and a medically accepted contraceptive method for the female partner (intra-uterine device with spermicide, hormonal contraceptive for at least two month prior trial participation)
Known fructose intolerance, glucose-galactose malabsorption, or saccharose-isomaltase deficiency
History of relevant liver diseases such as disturbance of liver function, jaundice, drug induced liver injury, Dubin-Johnson syndrome, Rotor syndrome, or liver tumours
Liver enzymes (ALT, AST, GGT) above upper limit of normal at the screening examination

Trial locations and contacts

1 site in 1 country.

Germany1 site

1346.10.1 Boehringer Ingelheim Investigational Site
Biberach

Other trials in Germany

About this study

Official title: Relative Bioavailability of a Single Oral Dose of BI 425809 When Administered Alone or in Combination With Multiple Oral Doses of Itraconazole in Healthy Male Subjects (an Open-label, Two-period, Fixed-sequence Trial)

To investigate whether and to what extent co-administration of multiple doses of itraconazole affect single dose pharmacokinetics of BI 425809 in healthy male subjects

Conditions: Healthy
Being tested: BI 425809, Itraconazole

What participants receive

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

BI 425809Drug
Also called Iclepertin
single dose BI 425809 tablet
ItraconazoleDrug
multiple doses of Itraconazole capsules

Study groups in NCT02342717
Study group	Role	What they receive
Treatment R (BI 425809 alone) then Treatment T (BI 425809 + Itraconazole)	Experimental	Treatment R: Subjects were administered single dose of 25 milligram (mg) BI 425809 (tablet) on Day 1. Treatment was administered orally with 240 mL of water after administration of a standardised breakfast. Treatment T: Subjects underwent 10 days of itraconazole (capsules) treatment (first day 200 mg itraconazole twice daily, followed by 9 days 200 mg itraconazole once daily) combined with a single dose of 25 mg BI 425809 (tablet) on the fourth day of the itraconazole treatment (1 h after the itraconazole administration). Treatments were administered orally with 240 mL of water after administration of a standardised breakfast or dinner. The BI 425809 single doses of treatments R and T were separated by a washout period of at least 16 days. Receives: Drug: BI 425809; Drug: Itraconazole

What is being measured

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

Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 to 167 h (AUC0-167)
AUC0-167 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 167 h);
Detailed sampling time points:
-2 hours (h), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 47h, 71h, 95h, 119h, 143h, 167h after Treatment R (BI 425809 single dose) administration; -2 hours (h), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 47h, 71h, 95h, 119h, 143h, 167h after Treatment T (Itraconazole multiple dose + BI 425809 single dose) administration
Measured: Treatment R: -2h predose on Day 1 of the reference period up to 167h postdose; Treatment T: -2h predose on Day 1 of this period up to 167h postdose (Treatment T occurred at least 16 days after Treatment R). See description for sampling timepoints.
Maximum Measured Concentration of BI 425809 in Plasma (Cmax)
Cmax (maximum measured concentration of the analyte in plasma);
Detailed sampling time points:
-2 hours (h), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 47h, 71h, 95h, 119h, 143h, 167h and 191h after Treatment R (BI 425809 single dose) administration; -2 hours (h), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 47h, 71h, 95h, 119h, 143h, 167h, 191h, 239h, 287h and 335h after Treatment T (Itraconazole multiple dose + BI 425809 single dose) administration
Measured: Treatment R: -2h predose on Day 1 of the reference period up to 167h postdose; Treatment T: -2h predose on Day 1 of this period up to 167h postdose (Treatment T occurred at least 16 days after Treatment R). See description for sampling timepoints.

Secondary outcomes (1)

Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity);
Detailed sampling time points:
-2 hours (h), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 47h, 71h, 95h, 119h, 143h, 167h and 191h after Treatment R (BI 425809 single dose) administration; -2 hours (h), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 47h, 71h, 95h, 119h, 143h, 167h, 191h, 239h, 287h and 335h after Treatment T (Itraconazole multiple dose + BI 425809 single dose) administration
Measured: Treatment R: -2h predose on Day 1 of the reference period up to 167h postdose; Treatment T: -2h predose on Day 1 of this period up to 167h postdose (Treatment T occurred at least 16 days after Treatment R). See description for sampling timepoints.

Timeline

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

29 Jan 201524 Mar 2015

First posted21 Jan 2015 (estimated)
Study start29 Jan 2015
Primary completion24 Mar 2015
Study completion24 Mar 2015

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.
Publications (1)Papers the sponsor has linked to this study.
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: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02342717
Sponsor's protocol ID: 1346.10
Other IDs: 2014-004855-29, 2014
Status last verified: Jul 2026
First submitted: 15 Jan 2015
Last updated: 2 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases(in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

Publications

Desch M, Wunderlich G, Goettel M, Goetz S, Liesenfeld KH, Chan TS, Rosenbrock H, Sennewald R, Link J, Keller S, Wind S. Effects of Cytochrome P450 3A4 Induction and Inhibition on the Pharmacokinetics of BI 425809, a Novel Glycine Transporter 1 Inhibitor. Eur J Drug Metab Pharmacokinet. 2022 Jan;47(1):91-103. doi: 10.1007/s13318-021-00723-y. Epub 2021 Oct 29.
PubMed 34716565

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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Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relative Bioavailability of a Single Oral Dose of BI 425809 When Administered Alone or in Combination With Multiple Oral Doses of Itraconazole in Healthy Male Subjects (an Open-label, Two-period, Fixed-sequence Trial)
ClinicalTrials.gov ID: NCT02342717
Acronym / sponsor ID: 1346.10
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 29 Jan 2015 (actual)
Primary completion: 24 Mar 2015 (actual)
Study completion: 24 Mar 2015 (actual)
First posted: 21 Jan 2015 (estimated)
Results: Posted 2 Oct 2026

Clinical summary

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

To investigate whether and to what extent co-administration of multiple doses of itraconazole affect single dose pharmacokinetics of BI 425809 in healthy male subjects

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment R (BI 425809 alone) then Treatment T (BI 425809 + Itraconazole)	Experimental	Drug: BI 425809, Drug: ItraconazoleTreatment R: Subjects were administered single dose of 25 milligram (mg) BI 425809 (tablet) on Day 1. Treatment was administered orally with 240 mL of water after administration of a standardised breakfast. Treatment T: Subjects underwent 10 days of itraconazole (capsules) treatment (first day 200 mg itraconazole twice daily, followed by 9 days 200 mg itraconazole once daily) combined with a single dose of 25 mg BI 425809 (tablet) on the fourth day of the itraconazole treatment (1 h after the itraconazole administration). Treatments were administered orally with 240 mL of water after administration of a standardised breakfast or dinner. The BI 425809 single doses of treatments R and T were separated by a washout period of at least 16 days.

Who may qualify

Ages: 18 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy male subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
Age of 18 to 50 years (incl.)
Body mass index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Key exclusion criteria (27 listed)

Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease judged as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

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 425809Also: Iclepertinsingle dose BI 425809 tablet	Drug	Treatment R (BI 425809 alone) then Treatment T (BI 425809 + Itraconazole)
Itraconazolemultiple doses of Itraconazole capsules	Drug	Treatment R (BI 425809 alone) then Treatment T (BI 425809 + Itraconazole)

Primary outcome

Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 to 167 h (AUC0-167)
Time frame: Treatment R: -2h predose on Day 1 of the reference period up to 167h postdose; Treatment T: -2h predose on Day 1 of this period up to 167h postdose (Treatment T occurred at least 16 days after Treatment R). See description for sampling timepoints.
AUC0-167 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 167 h); Detailed sampling time points: -2 hours (h), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 47h, 71h, 95h, 119h, 143h, 167h after Treatment R (BI 425809 single dose) administration; -2 hours (h), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 47h, 71h, 95h, 119h, 143h, 167h after Treatment T (Itraconazole multiple dose + BI 425809 single dose) administration
Maximum Measured Concentration of BI 425809 in Plasma (Cmax)
Time frame: Treatment R: -2h predose on Day 1 of the reference period up to 167h postdose; Treatment T: -2h predose on Day 1 of this period up to 167h postdose (Treatment T occurred at least 16 days after Treatment R). See description for sampling timepoints.
Cmax (maximum measured concentration of the analyte in plasma); Detailed sampling time points: -2 hours (h), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 47h, 71h, 95h, 119h, 143h, 167h and 191h after Treatment R (BI 425809 single dose) administration; -2 hours (h), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 47h, 71h, 95h, 119h, 143h, 167h, 191h, 239h, 287h and 335h after Treatment T (Itraconazole multiple dose + BI 425809 single dose) administration

1 secondary outcome

Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time frame: Treatment R: -2h predose on Day 1 of the reference period up to 167h postdose; Treatment T: -2h predose on Day 1 of this period up to 167h postdose (Treatment T occurred at least 16 days after Treatment R). See description for sampling timepoints.

Results and safety

Results posted to the registry on 2 Oct 2026, 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 R (BI 425809 Alone) Then Treatment T (BI 425809 + Itraconazole)	16	16

Primary outcome: Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 to 167 h (AUC0-167)

Time frame: Treatment R: -2h predose on Day 1 of the reference period up to 167h postdose; Treatment T: -2h predose on Day 1 of this period up to 167h postdose (Treatment T occurred at least 16 days after Treatment R). See description for sampling timepoints.. Geometric mean (Geometric Coefficient of Variation). Unit: nanomoles*hours/ Litres (nmol*h/L)

Measure	Treatment R (BI 425809 Alone) n = 16	Treatment T (BI 425809 + Itraconazole): n = 15
Value	10200 (29.7)	26800 (19.7)

Treatment R (BI 425809 Alone) vs Treatment T (BI 425809 + Itraconazole):: ratio of the geometric means (%): 265.31 (90% CI 240.88 to 292.22)

Population analysed: Pharmacokinetic set (PKS): Subjects in TS who provided at least 1 primary or secondary PK endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation of PK endpoints. (Evaluable cases)

Primary outcome: Maximum Measured Concentration of BI 425809 in Plasma (Cmax)

Measure	Treatment R (BI 425809 Alone) n = 16	Treatment T (BI 425809 + Itraconazole): n = 15
Value	316 (19.0)	366 (12.8)

Treatment R (BI 425809 Alone) vs Treatment T (BI 425809 + Itraconazole):: ratio of the geometric means (%): 116.06 (90% CI 108.039 to 124.683)

Population analysed: PKS

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Treatment R: from BI 425809 drug intake (day 1) up to 11 days (Residual Effect period [REP]) after; Treatment T (loading itraconazole): From the first intake of itraconazole on Day -3 up to 3 days after. For BI 425809 + itraconazole: From the intake of BI 425809 on Day 1 up to 11 days (REP) after.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment R (BI 425809 Alone)	0 of 16 (0%)	6 of 16 (37.5%)	Not reported
Treatment T (Loading Itraconazole)	0 of 16 (0%)	4 of 16 (25%)	Not reported
Treatment T (BI 425809 + Itraconazole)	0 of 16 (0%)	6 of 16 (37.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34716565Desch M, Wunderlich G, Goettel M, Goetz S, Liesenfeld KH, Chan TS, Rosenbrock H, Sennewald R, Link J, Keller S, Wind S. Effects of Cytochrome P450 3A4 Induction and Inhibition on the Pharmacokinetics of BI 425809, a Novel Glycine Transporter 1 Inhibitor. Eur J Drug Metab Pharmacokinet. 2022 Jan;47(1):91-103. doi: 10.1007/s13318-021-00723-y. Epub 2021 Oct 29.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases(in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

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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 425809 and Itraconazole in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

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 4 inclusion and 27 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 2 Oct 2026. 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 Germany. 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 2 Oct 2026). 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 Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 to 167 h (AUC0-167) (time frame: Treatment R: -2h predose on Day 1 of the reference period up to 167h postdose; Treatment T: -2h predose on Day 1 of this period up to 167h postdose (Treatment T occurred at least 16 days after Treatment R). See description for sampling timepoints.). The study lists 2 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 NCT02342717, which also lists 1 linked publication.

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 2 Oct 2026.