Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 17 of 62 for:    Baricitinib

A Study of Baricitinib and Rifampicin 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: NCT01910311
Recruitment Status : Completed
First Posted : July 29, 2013
Results First Posted : April 21, 2017
Last Update Posted : June 6, 2017
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purposes of this study are to look at what effect multiple doses of rifampicin have on a single dose of baricitinib and to look at the safety and tolerability of these drugs. Side effects will be documented. The study will last approximately 31 days from the first dose to the end of the study.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Baricitinib Drug: Rifampicin Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effect of CYP3A Induction by Rifampicin on the Pharmacokinetics of Baricitinib in Healthy Subjects
Study Start Date : August 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Rifampin

Arm Intervention/treatment
Experimental: Baricitinib
Single oral dose of 10 milligrams (mg) baricitinib on Day 1.
Drug: Baricitinib
Administered orally
Other Name: LY3009104

Experimental: Baricitinib + Rifampicin
Oral doses of 600 mg rifampicin once daily on Days 3 to 11, with a single oral dose of 10 mg baricitinib co-administered on Day 10.
Drug: Baricitinib
Administered orally
Other Name: LY3009104

Drug: Rifampicin
Administered orally




Primary Outcome Measures :
  1. PK: Maximum Concentration (Cmax) of Baricitinib [ Time Frame: Period 1, Day 1 and Period 2, Day 10: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose ]
  2. PK: Area Under the Concentration Versus Time Curve From 0 to Infinity [AUC(0-∞)] of Baricitinib [ Time Frame: Period 1, Day 1 and Period 2, Day 10: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose ]
  3. PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib [ Time Frame: Period 1, Day 1 and Period 2, Day 10: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose ]


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 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Are overtly healthy males or females
  • Male participants: Agree to use 2 reliable methods of birth control with female partners of childbearing potential during the study and for at least 3 months following the last dose of study drug
  • Female participants: Women not of childbearing potential due to surgical sterilization (at least 3 months after surgical hysterectomy, bilateral oophorectomy with or without hysterectomy, or bilateral tubal occlusion/ligation) confirmed by medical history, or menopause. Menopausal women are women with spontaneous amenorrhea for at least 12 months, not induced by a medical condition such as anorexia nervosa and not taking medications during the amenorrhea that induced the amenorrhea (for example, oral contraceptives, hormones, gonadotropin releasing hormone, anti-estrogens, selective estrogen receptor modulators, or chemotherapy). Menopausal status should be confirmed by a follicle-stimulating hormone (FSH) level greater than 40 international units per liter (IU/L) at screening [unless the participant is taking hormone replacement therapy (HRT)]
  • Have a body weight of ≥60 kilograms (kg) at the time of screening
  • Have clinical laboratory test results within normal reference range
  • Have normal renal function
  • Have normal blood pressure and pulse rate (supine position)
  • Have venous access sufficient to allow for blood sampling

Exclusion Criteria:

  • Are currently enrolled in, have completed, or discontinued within the last 90 days from a clinical trial involving a study drug, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
  • Have previously completed or withdrawn from this study or any other study investigating baricitinib, and have previously received the study drug
  • Have known allergies to baricitinib, rifampicin, related compounds, or any components of the baricitinib or rifampicin formulations, or history of significant atopy
  • Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
  • Have an average weekly alcohol intake that exceeds 28 units per week (males) and 21 units per week (females), or are unwilling to stop alcohol consumption 48 hours prior to the first dose and until completion of the safety follow-up assessment [Day 18 ± 1; 1 unit = 12 ounces (oz) or 360 milliliters (mL) of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits]
  • Have a history of, in the opinion of the investigator, excessive methylxanthine use within previous 6 months, such as greater than (>)6 cups of coffee (or equivalent) per day
  • Currently smoke more than 10 cigarettes per day or are unable to abide by Clinical Research Unit (CRU) restrictions
  • Are unwilling to refrain from using soft contact lenses from the start of the second treatment period until after the final follow-up

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): NCT01910311


Locations
Layout table for location information
United Kingdom
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Leeds, West Yorkshire, United Kingdom, LS2 9LH
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Layout table for investigator information
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company

Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01910311     History of Changes
Other Study ID Numbers: 14608
I4V-MC-JAGK ( Other Identifier: Eli Lilly and Company )
First Posted: July 29, 2013    Key Record Dates
Results First Posted: April 21, 2017
Last Update Posted: June 6, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Rifampin
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers