A Study in Healthy Male Participants to Compare How CHF10196 Affects How the Body Absorbs and Processes Two Commonly Used Medicines: Dabigatran, a Blood Thinner, and Rosuvastatin, a Medicine Used to Lower Cholesterol
29. Juli 2026 aktualisiert von: Chiesi Farmaceutici S.p.A.
An Open-label, Fixed-sequence, Non-randomized, Drug-drug Interaction Study to Evaluate the Effect of CHF10196 on the Pharmacokinetics of Dabigatran (P-gp Substrate) and Rosuvastatin (BCRP Substrate) in Healthy Male Participants.
The purpose of this study is to assess the potential drug-drug interaction of CHF10196 (a dipeptidyl peptidase 1 inhibitor) and its metabolite on the pharmacokinetics of dabigatran (a P-glycoprotein substrate) and Rosuvastatin (a breast cancer resistant protein substrate) in healthy male participants.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Geschätzt)
24
Phase
- Phase 1
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Chiesi Clinical Trial Info
- Telefonnummer: +39 0521 279 715
- E-Mail: Clinicaltrials_info@chiesi.com
Studienorte
-
-
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Leeds, Vereinigtes Königreich
- Fortrea Clinical Research Unit (CRU) Limited
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Kontakt:
- Jonathan Ackroyd
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-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Ja
Beschreibung
Inclusion Criteria:
- Healthy male participants aged 18 to 55 years
- Body mass index between 18.0 and 30.0 kg/m²
- Non-smokers or ex-smokers (<5 pack-years)
- Clinically healthy based on medical history and examination
- Vital signs and ECG within normal limits
- Willing and able to comply with study procedures
Exclusion Criteria:
- Use of prohibited concomitant medications
- Participation in another clinical study within 3 months
- Clinically relevant medical conditions
- Abnormal laboratory values
- Positive HIV, hepatitis B, or hepatitis C
- History of bleeding disorders
- Drug or alcohol abuse
- Use of nicotine-containing products within defined period
- Recent COVID-19 infection
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Sequenzielle Zuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Fixed-Sequence treatment
All participants will receive dabigatran alone and rosuvastatin alone in Treatment Period 1.
During Treatment Period 2, participants will receive CHF10196 alone, with dabigatran, and with rosuvastatin.
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Treatment period 1: Single dose administered on Day 1; Treatment period 2: Single dose administered on Day 13
Treatment period 1: Single dose administered on Day 4; Treatment period 2: Single dose administered on Day 16
Treatment period 2: Single dose administered daily from Day 8 to Day 19
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Pharmacokinetics of Dabigatran : AUC0-t
Zeitfenster: Up to 72 hours after dosing
|
comparing the ratios of adjusted geometric means between test 1 (dabigatran [free and total] with CHF10196) and reference 1 (dabigatran [free and total] alone), with 90% two-sided Confidential Intervals(CI), will be calculated for plasma dabigatran (free and total) area under the plasma concentration-time curve, from time 0 to the last measurable concentration (AUC0-t)
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Up to 72 hours after dosing
|
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Pharmacokinetics of Dabigatran: AUC0-∞
Zeitfenster: Up to 72 hours after dosing
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comparing the ratios of adjusted geometric means between test 1 (dabigatran [free and total] with CHF10196) and reference 1 (dabigatran [free and total] alone), with 90% two-sided CIs, will be calculated for plasma dabigatran (free and total) area under the plasma concentration-time curve, from time 0 to the last measurable concentration (AUC0-∞)
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Up to 72 hours after dosing
|
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Pharmacokinetics of Dabigatran: Cmax
Zeitfenster: Up to 72 hours after dosing
|
comparing the ratios of adjusted geometric means between test 1 (dabigatran [free and total] with CHF10196) and reference 1 (dabigatran [free and total] alone), with 90% two-sided CIs, will be calculated for plasma dabigatran (free and total) maximum observed maximum observed concentration (Cmax)
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Up to 72 hours after dosing
|
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Pharmacokinetics of Rosuvastatin :AUC0-t
Zeitfenster: Up to 96 hours after dosing
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The ratios of adjusted geometric means between test 2 (rosuvastatin with CHF10196) and reference 2 (rosuvastatin alone), with 90% two sided CIs, will be calculated for plasma rosuvastatin AUC0-t
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Up to 96 hours after dosing
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Pharmacokinetics of Rosuvastatin : AUC0-∞
Zeitfenster: Up to 96 hours after dosing
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The ratios of adjusted geometric means between test 2 (rosuvastatin with CHF10196) and reference 2 (rosuvastatin alone), with 90% two sided CIs, will be calculated for plasma rosuvastatin (AUC0-∞)
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Up to 96 hours after dosing
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Pharmacokinetics of Rosuvastatin: Cmax
Zeitfenster: Up to 96 hours after dosing
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The ratios of adjusted geometric means between test 2 (rosuvastatin with CHF10196) and reference 2 (rosuvastatin alone), with 90% two sided CIs, will be calculated for plasma rosuvastatin Cmax
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Up to 96 hours after dosing
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Safety and Tolerability : Incidence of adverse events (AE)
Zeitfenster: From Baseline Day -1 until Day 8 of TP1 and from Day 8 to Day 20 of TP2
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Number and percentage of study participants by treatment with AEs, adverse events of special interest(AESIs),treatment emergent adverse event(TEAEs), adverse drug reaction(ADRs), non-serious TEAEs, serious TEAEs, serious ADRs, severe TEAEs, TEAEs leading to study discontinuation and to death
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From Baseline Day -1 until Day 8 of TP1 and from Day 8 to Day 20 of TP2
|
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Safety and Tolerability : change from baseline for laboratory abnormalities
Zeitfenster: From Baseline Day -1 until Day 8 for TP1, and from Day 8 to Day 20 of TP 2
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Clinical laboratory abnormalities, based on haematology and blood chemistry test results by treatment period (TP). Number of participants with abnormal blood laboratory test results. Quantitative laboratory parameters (chemistry and haematology) will be summarised by treatment as absolute value and change from baseline using descriptive statistics |
From Baseline Day -1 until Day 8 for TP1, and from Day 8 to Day 20 of TP 2
|
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Safety and Tolerability: changes from baseline for vital signs - pulse rate
Zeitfenster: From Day 1 to Day 8 for TP1 and from Day 8 to Day 20 for TP2
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Mean changes from baseline to each post-dose timepoint in vital signs PR (pulse rate) by TP Baselines (the last value before the first administration of dabigatran etexilate of each TP or CHF10196 (TP2 only).
In TP2, two separate baselines will be derived relative to dabigatran and CHF10196)
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From Day 1 to Day 8 for TP1 and from Day 8 to Day 20 for TP2
|
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Safety and Tolerability: changes from baseline for vital signs - respiratory rate
Zeitfenster: From Day 1 to Day 8 for TP1 and from Day 8 to Day 20 for TP2
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Mean changes from baseline to each post-dose timepoint in vital signs RR (respiratory rate) by TP Baselines (the last value before the first administration of dabigatran etexilate of each TP or CHF10196 (TP2 only).
In TP2, two separate baselines will be derived relative to dabigatran and CHF10196)
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From Day 1 to Day 8 for TP1 and from Day 8 to Day 20 for TP2
|
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Safety and Tolerability: changes from baseline for vital signs - blood pressure
Zeitfenster: From Day 1 to Day 8 for TP1 and from Day 8 to Day 20 for TP2
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Mean changes from baseline to each post-dose timepoint in vital signs systolic blood pressure (SBP) and diastolic blood pressure (DBP) by TP. Baselines (the last value before the first administration of dabigatran etexilate of each TP or CHF10196 (TP2 only). In TP2, two separate baselines will be derived relative to dabigatran and CHF10196) |
From Day 1 to Day 8 for TP1 and from Day 8 to Day 20 for TP2
|
|
Safety and Tolerability : change from baseline for ECG intervals
Zeitfenster: From Day 1 to Day 8 for TP1 and from Day 8 to Day 20 for TP2
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Mean changes from baseline to each post-dose timepoint in 12-lead bedside ECG parameters. Intervals recorded: RR, PR, QT, QTc (Corrected QT interval), and QTcF (Fridericia corrected QT interval), and QRS duration by TP. Baselines (the last value before the first administration of dabigatran etexilate of each TP or CHF10196 (TP2 only). In TP2, two separate baselines will be derived relative to dabigatran and CHF10196) |
From Day 1 to Day 8 for TP1 and from Day 8 to Day 20 for TP2
|
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Safety and Tolerability : change from baseline for ECG HR
Zeitfenster: From Day 1 to Day 8 for TP1 and from Day 8 to Day 20 for TP2
|
Mean changes from baseline to each post-dose timepoint in 12-lead bedside ECG recording of Heart Rate (HR).
Baselines (the last value before the first administration of dabigatran etexilate of each TP or CHF10196 (TP2 only).
In TP2, two separate baselines will be derived relative to dabigatran and CHF10196)
|
From Day 1 to Day 8 for TP1 and from Day 8 to Day 20 for TP2
|
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Additional Pharmacokinetic Parameters : CL/F of dabigatran
Zeitfenster: From Day 1 to Day 4 for TP1 and from Day 13 to Day 16 for TP2
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total body clearance (CL/F) of dabigatran (free and total) will be analysed with descriptive statistics by TP
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From Day 1 to Day 4 for TP1 and from Day 13 to Day 16 for TP2
|
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Additional Pharmacokinetic Parameters: CL/F of resuvastatin
Zeitfenster: From Day 4 to Day 8 for TP1 and from Day 16 to Day 20 for TP2
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total body clearance (CL/F) of rosuvastatin will be analysed with descriptive statistics by TP
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From Day 4 to Day 8 for TP1 and from Day 16 to Day 20 for TP2
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Additional Pharmacokinetic Parameters: Vd/F of dabigatran
Zeitfenster: From Day 1 to Day 4 for TP1 and from Day 13 to Day 16 for TP2
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Apparent volume of distribution (Vd/F) of dabigatran (free and total) will be analysed with descriptive statistics by TP
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From Day 1 to Day 4 for TP1 and from Day 13 to Day 16 for TP2
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Additional Pharmacokinetic Parameters: Vd/F of rosuvastatin
Zeitfenster: From Day 4 to Day 8 for TP1 and from Day 16 to Day 20 forTP2
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Apparent volume of distribution (Vd/F) of rosuvastatin will be analysed with descriptive statistics by TP
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From Day 4 to Day 8 for TP1 and from Day 16 to Day 20 forTP2
|
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Additional Pharmacokinetic Parameters: tmax of dabigatran
Zeitfenster: From Day 1 to Day 4 for TP1 and from Day 13 to Day 16 for TP2
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Difference in median plasma tmax of dabigatran (free and total) between test 1 (dabigatran [free and total] with CHF10196) and reference 1 (dabigatran [free and total] alone) with 90% two-sided CIs
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From Day 1 to Day 4 for TP1 and from Day 13 to Day 16 for TP2
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Additional Pharmacokinetic Parameters: tmax of rosuvastatin
Zeitfenster: From Day 4 to Day 8 for TP1 and from Day 16 to Day 20 for TP2
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Difference in median plasma tmax of rosuvastatin between test 2 (rosuvastatin with CHF10196) and reference 2 (rosuvastatin alone) with 90% two-sided CIs
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From Day 4 to Day 8 for TP1 and from Day 16 to Day 20 for TP2
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Jonathan Ackroyd, Fortrea Clinical Research Unit (CRU)
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
27. Oktober 2026
Primärer Abschluss (Geschätzt)
15. Dezember 2028
Studienabschluss (Geschätzt)
15. Dezember 2028
Studienanmeldedaten
Zuerst eingereicht
23. Juli 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
29. Juli 2026
Zuerst gepostet (Tatsächlich)
4. August 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
4. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
29. Juli 2026
Zuletzt verifiziert
1. Juli 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Schwefelverbindungen
- Organische Chemikalien
- Pyridinen
- Heterocyclische Verbindungen, 1-Ring
- Heterocyclische Verbindungen
- Benzimidazoles
- Heterocyclische Verbindungen, 2-Ring
- Heterocyclische Verbindungen, Fusionsring
- Kohlenwasserstoffe
- Amides
- Pyrimidine
- Kohlenwasserstoffe, halogeniert
- Sulfonamide
- Sulfone
- Fluorobenzene
- Kohlenwasserstoffe, fluoriert
- Dabigatran
- Rosuvastatin Calcium
Andere Studien-ID-Nummern
- CLI-10196AA1-06
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Beschreibung des IPD-Plans
Chiesi clinical data sharing scope, process and data access criteria is available on the Chiesi Group website.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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