ClinicalTrials.gg
RecruitingNCT07837648Updated Oct 19, 2026

A Study to Test How Much BI 3034701 Gets Into the Blood in Healthy People When Given in Two Different Ways

A Phase 1 interventional study of BI3034701 formulation II and BI3034701 formulation C1 in Healthy, sponsored by Boehringer Ingelheim. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2026; still recruiting 1 month later.
Updated Oct 19, 2026Now RecruitingFirst site in United Kingdom+3 moreGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The aim of the trial is to investigate relative bioavailability of BI 3034701 treatment T vs. BI 3034701 treatment R.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,304 studies on the registry; 62 are open to participants now.

Of its 167 completed or terminated interventional studies of FDA-regulated products, 123 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy male or female trial participant according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead (ECG), and clinical laboratory tests
  2. Age of 18 to 55 years (inclusive) at screening
  3. (BMI) of 20.0 to 32.0 kg/m\^2 (inclusive) at screening
  4. Signed and dated written in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) and local legislation prior to admission to the trial
  5. Women of (WOCBP) must be ready and able to use highly effective methods of per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.

Exclusion criteria

Exclusion Criteria:

  1. Any finding in the medical examination (including BP, PR or ) deviating from and assessed as by the investigator
  2. 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
  3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
  4. Further exclusion criteria apply.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Reference treatment (R), then Test treatment (T)

    BI3034701 formulation II (R), then BI3034701 formulation C1 (T)

    Drug: BI3034701 formulation II · Drug: BI3034701 formulation C1

  • Experimental
    Test treatment (T), then Reference treatment (R)

    BI3034701 formulation C1 (T), then BI3034701 formulation II (R)

    Drug: BI3034701 formulation II · Drug: BI3034701 formulation C1

Interventions

06

What researchers measure

Primary outcomes

  1. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)

    Time frame: Up to 19 days.

  2. Maximum measured concentration of the analyte in plasma (Cmax)

    Highest observed plasma concentrations within the time interval.

    Time frame: Up to 19 days.

Secondary outcomes

  1. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

    Time frame: Up to 19 days.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Related links

Individual participant data

Plan to share: 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

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Oct 19, 2026
Sites
1 site added — first site in United Kingdom
Show site
  • Quotient Sciences · Nottingham, United Kingdom
Oct 19, 2026
Study completion
Dec 15, 2026→Dec 24, 2026
Oct 19, 2026
Interventions
Changed BI3034701 formulation B→BI3034701 formulation II
Oct 19, 2026
Show all 1 update
  1. Oct 19, 2026
    Not yet recruiting→Recruiting
    1 site added — first site in United Kingdom
    Show site
    • Quotient Sciences · Nottingham, United Kingdom
    Study completion Dec 15, 2026→Dec 24, 2026
    Interventions Changed BI3034701 formulation B→BI3034701 formulation II
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07837648
Responsible party
Sponsor
First posted
Sep 23, 2026
Start date
Oct 5, 2026
Primary completion
Dec 15, 2026 (estimated)
Completion
Dec 24, 2026 (estimated)
Last update
Oct 19, 2026

Study contacts

Boehringer Ingelheim
Contact
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: BI 3034701

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