Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02611518
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : April 5, 2016
Actual Primary Completion Date : June 14, 2016
Actual Study Completion Date : June 14, 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Up to Day 17 ]
    The Cmax is the maximum observed concentration.

  2. Area Under the Plasma Concentration‐Time Curve From Time Zero to Last Quantifiable Time (AUC [0‐last]) [ Time Frame: Up to Day 17 ]
    The AUC (0‐last) is the area under the plasma concentration‐time curve from time zero to last quantifiable time.

  3. Area Under the Plasma Concentration‐Time Curve From Time Zero to Infinite Time (AUC[0‐infinity]) [ Time Frame: 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 :
  1. Number of Participants with Adverse Events [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02611518


Locations
Layout table for location information
Germany
Berlin, Germany
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Layout table for investigator information
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02611518    
Other Study ID Numbers: CR108091
54861911ALZ1012 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

Layout table for additional information
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janssen Research & Development, LLC:
Healthy
JNJ-54861911
Rosuvastatin
Metformin
Additional relevant MeSH terms:
Layout table for MeSH terms
Metformin
Rosuvastatin Calcium
Hypoglycemic Agents
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors