A Pharmacokinetic Interaction Study Between JNJ-54861911 and Transporter Substrates Rosuvastatin and Metformin in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to look at how taking JNJ-54861911 every day will effect the amount of rosuvastatin or metformin in your blood after taking only a single dose of either one.

Detailed Description
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This is an open-label (all people know the identity of the intervention), single-center, fixed sequence, 2-panel study in a total of 32 healthy adult participants (16 participants per panel). The study consists of 3 phases: a Screening Phase of approximately 3 weeks (Days -22 to -2), an Open-Label Treatment Phase consisting of a single 19 day Treatment Period for Panel 1 (Days -1 to 18) or a single 18 day Treatment Period for Panel 2 (Days -1 to 17) and a Follow-up Phase of 5 to 7 days. In Panel 1, each participant will be administered a single oral dose of 10 milligram (mg) rosuvastatin on Day 1 and Day 14. Participants will receive JNJ-54861911 at a dose of 25 mg once daily from Day 8 until Day 17. In Panel 2, each participant will be administered a single oral dose of 500 mg metformin on Day 1 and Day 14. Participants will receive JNJ-54861911 at a dose of 25 mg once daily from Day 8 until Day 16. Participants' safety will be monitored throughout the study.

Official Title
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A Phase 1, 2-Panel, Open-Label, Fixed-Sequence Study in Healthy Adult Subjects to Investigate the Pharmacokinetic Interaction Between JNJ-54861911 and Transporter Substrates Rosuvastatin and Metformin

Conditions
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Healthy

Intervention / Treatment
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* Drug: Rosuvastatin
* Drug: JNJ-54861911
* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study Willing to adhere to the prohibitions and restrictions specified in this protocol All woman must have a negative serum pregnancy test at Screening and on Day minus (-) 1 of the Treatment Period If a woman must not be of childbearing potential: postmenopausal (greater than [>]45 years of age with amenorrhea for at least 12 months, or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone {FSH} level >40 International Units /Litre [IU/L]); documented permanently sterilized (example, tubal occlusion, hysterectomy, bilateral salpingectomy); or otherwise be incapable of pregnancy If a woman, must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 3 months after receiving the last dose of study drug Non-smoker Exclusion Criteria: Known allergy to rosuvastatin, metformin, JNJ-54861911 or to heparin or history of heparin induced thrombocytopenia History of or current clinically significant medical illness or a clinically significant 12-lead electrocardiogram (ECG) abnormality Donated blood or blood products or had substantial loss of blood (more than 500 milliliter [mL]) within 3 months before the first administration of study drug or intention to donate blood or blood products during the study Received an experimental drug or used an experimental medical device within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before the first dose of the study drug is scheduled Unable to swallow solid, oral dosage forms whole with the aid of water If a man, who plans to father a child while enrolled in the study or for 3 months after receiving the last dose of study drug Vulnerable participants Participants should not be enrolled if they have exposure to radiologic or magnetic resonance studies involving the use of intravascular contrast materials (for example, computed tomography [CT] scans with intravascular contrast materials), within 48 hours prior to Screening and for duration of study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Panel 1<br>Participant will be administered a single oral dose of rosuvastatin 10 milligram (mg) on Day 1 and Day 14 and JNJ-54861911 at a dose of 25 mg once daily from Day 8 until Day 17. | Drug: Rosuvastatin<br>* Rosuvastatin will be administered as a single oral 10 milligram (mg) dose on Day 1 and Day 14.<br>Drug: JNJ-54861911<br>* JNJ-54861911 will be administered at a dose of 25 mg once daily from Day 8 to Day 17 (in panel 1), Day 8 to 16 (in panel 2).<br>|
| Experimental: Panel 2<br>Participant will be administered a single oral dose of metformin 500-mg on Day 1 and Day 14 and JNJ-54861911 at a dose of 25 mg once daily from Day 8 until Day 16. | Drug: JNJ-54861911<br>* JNJ-54861911 will be administered at a dose of 25 mg once daily from Day 8 to Day 17 (in panel 1), Day 8 to 16 (in panel 2).<br>Drug: Metformin<br>* Metformin will be administered as a single oral 500 mg on Day 1 and Day 14.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) | The Cmax is the maximum observed concentration. | Up to Day 17 | 
| Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) | The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time. | Up to Day 17 | 
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) | The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC (last) and C(last)/lambda(z); wherein AUC (last) is area under the plasma concentration time curve from time zero to last quantifiable time, C (last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant. | Up to Day 17 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events | An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | Up to follow-up (5-7 Days after last dose of study drug administration) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy, JNJ-54861911, Rosuvastatin, Metformin