A Study of LY3009104 for Healthy Subjects - Full Text View

Purpose

To evaluate the safety and tolerability of LY3009104 when given orally as single and multiple doses in Japanese healthy subjects.

Condition	Intervention	Phase
Healthy Volunteer	Drug: LY3009104 Drug: Placebo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3009104 in Japanese Healthy Subjects

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Number of participants with clinically significant effects [ Time Frame: baseline to study completion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetics, maximum concentration (Cmax) [ Time Frame: baseline, days 1, 2 and 3 for cohort 1 and 2/ baseline, days 1, 2, 3, 17, 18 and 19 for cohort 3 and 4 ] [ Designated as safety issue: No ]
Pharmacokinetics, area under the concentration versus time curve (AUC) [ Time Frame: baseline, days 1, 2 and 3 for cohort 1 and 2/ baseline, days 1, 2, 3, 17, 18 and 19 for cohort 3 and 4 ] [ Designated as safety issue: No ]
Pharmacokinetics, half-life(t1/2) [ Time Frame: baseline, days 1, 2 and 3 for cohort 1 and 2/ baseline, days 1, 2, 3, 17, 18 and 19 for cohort 3 and 4 ] [ Designated as safety issue: No ]
Pharmacokinetics, apparent volume of distribution (V/F) [ Time Frame: baseline, days 1, 2 and 3 for cohort 1 and 2/ baseline, days 1, 2, 3, 17, 18 and 19 for cohort 3 and 4 ] [ Designated as safety issue: No ]
Pharmacokinetics, apparent total body clearance (CL/F) [ Time Frame: baseline, days 1, 2 and 3 for cohort 1 and 2/ baseline, days 1, 2, 3, 17, 18 and 19 for cohort 3 and 4 ] [ Designated as safety issue: No ]
Pharmacokinetics, time of maximum observed drug concentration(tmax) [ Time Frame: baseline, days 1, 2 and 3 for cohort 1 and 2/ baseline, days 1, 2, 3, 17, 18 and 19 for cohort 3 and 4 ] [ Designated as safety issue: No ]
Pharmacokinetics, renal excretion [ Time Frame: baseline, days 1 and 17 for cohort 3 and 4 ] [ Designated as safety issue: No ]

Enrollment:	34
Study Start Date:	November 2010
Study Completion Date:	April 2011
Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Cohort 1 2mg administered once on day 1	Drug: LY3009104 Administered orally
Experimental: Cohort 2 5mg administered once on day 1	Drug: LY3009104 Administered orally
Experimental: Cohort 3 10 mg administered on day 1 and following a 7 day washout period, administered once daily for 10 days	Drug: LY3009104 Administered orally
Experimental: Cohort 4 14 mg administered on day 1 and following a 7 day washout period, administered once daily for 10 days	Drug: LY3009104 Administered orally
Placebo Comparator: Placebo	Drug: Placebo Administered orally

Eligibility

Criteria

Inclusion Criteria:

Healthy males or females. Male subjects:Agree to use 2 forms of highly effective methods of birth control with female partners of childbearing potential for the specified duration. Female subjects: Females must not be pregnant, breastfeeding, or at risk to become pregnant during study participation. Female subjects of childbearing potential must test negative for pregnancy at screening and agree to use 2 forms of highly effective methods of birth control, or remain abstinent for the specified duration.
Up to third generation Japanese, that is defined as all of the subject's biological grandparents are of exclusive Japanese decent and have been born in Japan.
Are between the body mass index (BMI) of 18.0 and 30.0 kg/m^2, inclusive at screening.

Exclusion Criteria:

Are subjects who have previously completed or withdrawn from this study or any other study investigating LY3009104, and received the study drug.
Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data.
Show evidence of significant active neuropsychiatric disease.
Have current or recent history of herpes zoster or simplex in the last 90 days prior to randomization, or history of herpes zoster, such as disseminated herpes zoster involving multiple dermatomes, ocular involvement, including herpes zoster involving the ophthalmic branch of the trigeminal nerve.
Have or have a history of rheumatoid arthritis.
History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin.
History of stomach or intestinal surgery, except that appendectomy and/or cholecystectomy will be allowed.
Receipt of blood products within 2 months prior to study entry.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01247350

Locations

United States, Hawaii
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.
Honolulu, Hawaii, United States

Sponsors and Collaborators

Eli Lilly and Company

Investigators

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

More Information

No publications provided

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT01247350 History of Changes
Other Study ID Numbers:	14089, I4V-JE-JADM
Study First Received:	November 17, 2010
Last Updated:	May 12, 2011
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 19, 2013