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

Sponsor

Janssen Research & Development, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT02611518

Collaborator

(none)

Enrollment

Location

Arms

2.3

Actual Duration (Months)

13.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Rosuvastatin Drug: JNJ-54861911 Drug: Metformin	Phase 1

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 5, 2016

Actual Primary Completion Date :

Jun 14, 2016

Actual Study Completion Date :

Jun 14, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Panel 1 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 Rosuvastatin will be administered as a single oral 10 milligram (mg) dose on Day 1 and Day 14. Drug: JNJ-54861911 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).
Experimental: Panel 2 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 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). Drug: Metformin Metformin will be administered as a single oral 500 mg on Day 1 and Day 14.

Arm

Intervention/Treatment

Experimental: Panel 1

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

Rosuvastatin will be administered as a single oral 10 milligram (mg) dose on Day 1 and Day 14.

Drug: JNJ-54861911

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).

Experimental: Panel 2

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

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).

Drug: Metformin

Metformin will be administered as a single oral 500 mg on Day 1 and Day 14.

Outcome Measures

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) [Up to Day 17]
The Cmax is the maximum observed concentration.
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) [Up to Day 17]
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) [Up to Day 17]
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.

Secondary Outcome Measures

Number of Participants with Adverse Events [Up to follow-up (5-7 Days after last dose of study drug administration)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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 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