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

NCT02611518 | Completed Phase 1

• 2 other identifiers: CR10809154861911ALZ1012
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Healthy; JNJ-54861911; Rosuvastatin; Metformin

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Number of Participants with Adverse Events

  Up to follow-up (5-7 Days after last dose of study drug administration)

Study Arms (2)

Panel 1

EXPERIMENTAL

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; Drug: JNJ-54861911

Panel 2

EXPERIMENTAL

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; Drug: Metformin

Interventions

Rosuvastatin DRUG

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

Panel 1

JNJ-54861911 DRUG

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).

Panel 1; Panel 2

Metformin DRUG

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

Panel 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Berlin, Germany

Location

MeSH Terms

Interventions

Rosuvastatin Calcium; atabecestat; Metformin

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biguanides; Guanidines; Amidines

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: November 20, 2015
• Study Start: April 5, 2016
• Primary Completion: June 14, 2016
• Study Completion: June 14, 2016
• Last Updated: February 3, 2025

Record last verified: 2025-01

Locations

DE (1)