Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: LY3154885 - Capsule Drug: Placebo - Capsule Drug: Itraconazole Drug: LY3154885 - Tablet | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 36 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Masking: | Double (Participant, Investigator) |
Masking Description: | Part D will be open-label. |
Primary Purpose: | Basic Science |
Official Title: | Single- and Multiple-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study With LY3154885 in Healthy Subjects |
Actual Study Start Date : | August 9, 2019 |
Actual Primary Completion Date : | February 9, 2020 |
Actual Study Completion Date : | February 9, 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: LY3154885 - Part A
LY3154885 administered orally in two of three study periods.
|
Drug: LY3154885 - Capsule
Administered orally.
|
Placebo Comparator: Placebo - Part A
Placebo administered orally in one of three study periods.
|
Drug: Placebo - Capsule
Administered orally.
|
Experimental: LY3154885 - Part B
LY3154885 administered orally alone.
|
Drug: LY3154885 - Capsule
Administered orally.
|
Placebo Comparator: Placebo - Part B
Placebo administered orally alone.
|
Drug: Placebo - Capsule
Administered orally.
|
Experimental: LY3154885 + Itraconazole - Part B
LY3154885 administered alone, orally, once. Itraconazole administered alone, orally, on consecutive days. LY3154885 co-administered with itraconazole, orally, once.
|
Drug: LY3154885 - Capsule
Administered orally.
Drug: Itraconazole Administered orally.
|
Placebo Comparator: Placebo + Itraconazole - Part B
Placebo administered alone, orally, once. Itraconazole administered alone, orally, on consecutive days. Placebo co-administered with itraconazole, orally, once.
|
Drug: Placebo - Capsule
Administered orally.
Drug: Itraconazole Administered orally.
|
Experimental: LY3154885 - Part C
LY3154885 administered orally on consecutive days.
|
Drug: LY3154885 - Capsule
Administered orally.
|
Placebo Comparator: Placebo - Part C
Placebo administered orally on consecutive days.
|
Drug: Placebo - Capsule
Administered orally.
|
Experimental: LY3154885 - Part D
LY3154885 administered orally once in each of three study periods.
|
Drug: LY3154885 - Capsule
Administered orally.
Drug: LY3154885 - Tablet Administered orally.
|
Ages Eligible for Study: | 21 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Male participants:
Female participants of nonchildbearing potential, including those who are:
Postmenopausal, defined as 1 of the following:
A woman at least 50 years of age with an intact uterus, not on hormone replacement therapy, who has had either:
Exclusion Criteria:
Have a marked baseline prolongation of/corrected QT (QTc) interval (for example, repeated demonstration of a QTcB interval >450 milliseconds [msec] for males or >470 msec for females);
United States, Texas | |
Covance | |
Dallas, Texas, United States, 75247 |
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 |
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | July 9, 2019 | ||||
First Posted Date ICMJE | July 10, 2019 | ||||
Last Update Posted Date | October 19, 2020 | ||||
Actual Study Start Date ICMJE | August 9, 2019 | ||||
Actual Primary Completion Date | February 9, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline through Study Completion (up to 70 days) ] A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
|
||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study of LY3154885 in Healthy Participants | ||||
Official Title ICMJE | Single- and Multiple-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study With LY3154885 in Healthy Subjects | ||||
Brief Summary | The main purpose of this study is to learn more about the safety and side effects of LY3154885 when given by mouth to healthy participants. The study will have up to four parts. Each participant will enroll in only one part. The study will last up to 70 days for each participant, including screening and follow-up. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Sequential Assignment Masking: Double (Participant, Investigator) Masking Description: Part D will be open-label. Primary Purpose: Basic Science
|
||||
Condition ICMJE | Healthy | ||||
Intervention ICMJE |
|
||||
Study Arms ICMJE |
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Actual Enrollment ICMJE |
36 | ||||
Original Estimated Enrollment ICMJE |
102 | ||||
Actual Study Completion Date ICMJE | February 9, 2020 | ||||
Actual Primary Completion Date | February 9, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 21 Years to 65 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04014361 | ||||
Other Study ID Numbers ICMJE | 17051 J1Z-MC-HUAA ( Other Identifier: Eli Lilly and Company ) |
||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE |
|
||||
Responsible Party | Eli Lilly and Company | ||||
Study Sponsor ICMJE | Eli Lilly and Company | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
|
||||
PRS Account | Eli Lilly and Company | ||||
Verification Date | October 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |