NCT01247350CompletedPhase 1
A Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3009104 in Japanese Healthy Subjects
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Number of Participants With Clinically Significant Effects
Study Overview
Brief Summary
To evaluate the safety and tolerability of LY3009104 when given orally as single and multiple doses in Japanese healthy subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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/m², 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- •Are subjects who have previously completed or withdrawn from this study or any other study investigating LY3009104, and received the study drug.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.
Arms & Interventions
2 mg LY3009104 (Cohort 1)
Experimental
2mg administered once on day 1 (single dose)
Intervention: LY3009104 (Drug)
5 mg LY3009104 (Cohort 2)
Experimental
5mg administered once on day 1 (single dose)
Intervention: LY3009104 (Drug)
10 mg LY3009104 (Cohort 3)
Experimental
10 mg administered on day 1 (single dose) and following a 7 day washout period, administered once daily for 10 days (multiple dose)
Intervention: LY3009104 (Drug)
14 mg LY3009104 (Cohort 4 )
Experimental
14 mg administered on day 1 (single dose) and following a 7 day washout period, administered once daily for 10 days (multiple dose)
Intervention: LY3009104 (Drug)
Placebo
Placebo Comparator
administered on day 1 (single dose) and following a 7 day washout period, administered once daily for 10 days (multiple dose)
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Number of Participants With Clinically Significant Effects
Time Frame: Days 1-10 for Cohorts 1 & 2, Days 1-7 for single dose of Cohorts 3 & 4, Days 8-31 for multiple doses
Adverse events were considered clinically significant effects. A summary of serious adverse events and other nonserious adverse events are located in the Reported Adverse Event section.
Secondary Outcomes
- Pharmacokinetics: Maximum Concentration (Cmax) of LY3009104(Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose)
- Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY3009104(Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose)
- Pharmacokinetics: Half-Life(t1/2) of LY3009104(Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose)
- Pharmacokinetics: Apparent Total Body Clearance of LY3009104(Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 38 and 48 hours postdose)
- Pharmacokinetics: Time of Maximum Observed LY3009104 Concentration (Tmax)(Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 38 and 48 hours postdose)
- Pharmacokinetics: Renal Excretion of LY3009104(Day 1: continuous for 24 hours)
- Pharmacokinetics: Apparent Volume of Distribution of LY3009104(Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose)
Investigators
Study Sites (1)
Loading locations...
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