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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02611518
• Date of registration: 19/11/2015
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• Public title: A Pharmacokinetic Interaction Study Between JNJ-54861911 and Transporter Substrates Rosuvastatin and Metformin in Healthy Participants
• Scientific 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
• Date of first enrolment: April 5, 2016
• Target sample size: 32
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02611518
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Germany

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Metformin

Drug: Rosuvastatin

Drug: JNJ-54861911

Primary Outcome(s)

Maximum Observed Plasma Concentration (Cmax) [Time Frame: Up to Day 17]

Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) [Time Frame: Up to Day 17]

Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) [Time Frame: Up to Day 17]

Secondary Outcome(s)

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

Secondary ID(s)

CR108091

54861911ALZ1012

Source(s) of Monetary Support

Please refer to primary and secondary sponsors