A Study in Healthy Men and Women to Test if Taking Different Formulations of BI 730357 Tablets Influences the Amount of BI 730357 in the Blood

NCT03886272 | Completed Phase 1 Results

• 2 other identifiers: 1407-00322018-004421-91
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of Trial Parts 1 and 2 is to investigate the relative bioavailability of two tablet strengths (low dose and high dose) of the intended Commercial Formulation of BI 730357 (Test, T) versus with the corresponding tablet strengths of Trial Formulation 1 (Reference, R). The main objective of Trial Part 3 is to investigate the relative bioavailability of two iCF side batches of BI 730357 with coarse milled Active pharmaceutical ingredient (API)(Test coarse milled, Tc) and unmilled API (Test unmilled, Tu), respectively, versus the final iCF batch of BI 730357 with regularly milled API (Reference, R).

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area Under the Concentration-time Curve of BI 730357 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

  Area under the concentration-time curve of BI 730357 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).

  Within 3 hours before and 0.5, 1, 1.5, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, 71, 119 and 167 hours after drug administration.

• Maximum Measured Concentration of BI 730357 in Plasma (Cmax)

  Maximum measured concentration of BI 730357 in plasma (Cmax).

  Within 3 hours before and 0.5, 1, 1.5, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, 71, 119 and 167 hours after drug administration.

Secondary Outcomes (1)

• Area Under the Concentration-time Curve of BI 730357 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

  Within 3 hours before and 0.5, 1, 1.5, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, 71, 119 and 167 hours after drug administration.

Study Arms (2)

BI 730357 (Test)

EXPERIMENTAL

Drug: BI 730357 (Test)

BI 730357 (Reference)

EXPERIMENTAL

Drug: BI 730357 (Reference)

Interventions

BI 730357 (Test) DRUG

tablet

BI 730357 (Test)

BI 730357 (Reference) DRUG

tablet

BI 730357 (Reference)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), PR), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
• Age of 18 to 50 years (inclusive)
• Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
• Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
• Male subjects, or female subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion:
• Use of adequate contraception, e.g. any of the following methods plus condom:
• \--- implants, injectables, combined oral or vaginal contraceptives, intrauterine device
• Sexually abstinent
• A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)
• Surgically sterilised (including hysterectomy)
• Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with levels of Follicle-stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)

You may not qualify if:

• Any finding in the medical examination (including Blood pressure (BP), PR or Electrocardiogram (ECG)) deviating from normal and assessed 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 45 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 assessed as clinically relevant by the investigator
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
• 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)
• Use of drugs within 30 days of planned administration of trial medication that might reasonably influence the results of the trial (including drugs that cause QT/QTc interval prolongation)
• Intake of an investigational drug in another clinical trial within 60 days of planned administration of investigational drug in the current trial, or concurrent participation in another clinical trial in which investigational drug is administered
• 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 12 g per day for females and 24 g per day for males)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Location

Related Publications (1)

• Ooi QX, Kristoffersson A, Korell J, Flack M, L Plan E, Weber B. Bounded integer model-based analysis of psoriasis area and severity index in patients with moderate-to-severe plaque psoriasis receiving BI 730357. CPT Pharmacometrics Syst Pharmacol. 2023 Jun;12(6):758-769. doi: 10.1002/psp4.12948. Epub 2023 May 1.

  PMID: 36919398 DERIVED

Related Links

• Related Info

Results Point of Contact

• Title: Boehringer Ingelheim, Call Centre
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: March 22, 2019
• Study Start: April 11, 2019
• Primary Completion: June 21, 2019
• Study Completion: June 21, 2019
• Last Updated: July 17, 2023
• Results First Posted: July 17, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)