## Protocol Section
### Identification Module
**NCT ID:** NCT02963779

**Brief Title:** A Study of LY2775240 in Healthy Participants

**Official Title:** A 2-Part, Safety, Tolerability, and Pharmacokinetic Study of LY2775240 in Healthy Subjects

#### Organization Study ID Info
**ID:** 16450
#### Organization
**Class:** INDUSTRY
**Full Name:** Eli Lilly and Company
#### Secondary ID Infos
**Domain:** Eli Lilly and Company
**ID:** I8W-MC-PDBA
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2017-10-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-11-07

**Type:** ACTUAL

**Last Update Submit Date:** 2017-11-03

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-10-05

**Type:** ACTUAL

#### Start Date
**Date:** 2016-12

**Status Verified Date:** 2017-11

#### Study First Post Date
**Date:** 2016-11-15
**Type:** ESTIMATED
**Study First Submit Date:** 2016-11-10
**Study First Submit QC Date:** 2016-11-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Eli Lilly and Company

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study is conducted to determine the side effects related to LY2775240 given orally to healthy participants. Blood tests will be done to check how much LY2775240 is absorbed into the bloodstream and how long the body takes to get rid of it. Each participant will enroll in either Part A or Part B of the study, which will last about 14 weeks and 8 weeks respectively, including screening.

### Conditions Module

**Conditions:**

- Healthy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 35

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Escalating oral doses of LY2775240 administered in healthy participants

**Intervention Names:**

- Drug: LY2775240

**Label:** LY2775240 (Part A)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Oral dose of LY2775240 in healthy participants

**Intervention Names:**

- Drug: LY2775240

**Label:** LY2775240 (Part B)

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Placebo administered orally in healthy participants

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo (Part A)

**Type:** PLACEBO_COMPARATOR

#### Arm Group 4

**Description:** Oral dose of apremilast in healthy participants

**Intervention Names:**

- Drug: Apremilast

**Label:** Apremilast (Part B)

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- LY2775240 (Part A)

- LY2775240 (Part B)

**Description:** Administered orally

**Name:** LY2775240

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo (Part A)

**Description:** Administered orally

**Name:** Placebo

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Apremilast (Part B)

**Description:** Administered orally

**Name:** Apremilast

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** 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 to final follow-up at approximately Week 14

#### Secondary Outcomes

**Measure:** Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2775240

**Time Frame:** Baseline through Day 5

**Measure:** Pharmacokinetics: Time to Maximal Blood Concentration of LY2775240

**Time Frame:** Baseline through Day 5

**Measure:** Pharmacokinetics: Maximum Concentration of LY2775240 in Blood

**Time Frame:** Baseline through Day 5

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Overtly healthy adult male or a female who cannot get pregnant
* Have a screening body mass index (BMI) of greater than 18 and less than or equal to 32 kilograms per meter square (kg/m²), inclusive
* Have normal blood pressure, pulse rate, electrocardiogram (ECG) and medical test results that are acceptable for the study

Exclusion Criteria:

* Are currently participating in or completed a clinical trial within the last 30 days from a clinical trial or any other type of medical research judged to be incompatible with this study
* Have known allergies to compounds or drugs similar to LY2775240 or apremilast
* Have previously participated or withdrawn from this study
* Have or used to have health problems or medical test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 21 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Singapore

**Country:** Singapore

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

#### Overall Officials

**Official 1:**

**Affiliation:** Eli Lilly and Company

**Name:** 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)

**Role:** STUDY_DIRECTOR

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000000894

- Term: Anti-Inflammatory Agents, Non-Steroidal

- ID: D000018712

- Term: Analgesics, Non-Narcotic

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000893

- Term: Anti-Inflammatory Agents

- ID: D000018501

- Term: Antirheumatic Agents

- ID: D000058988

- Term: Phosphodiesterase 4 Inhibitors

- ID: D000010726

- Term: Phosphodiesterase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: Analg

- Name: Analgesics

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M341074

- Name: Apremilast

- Relevance: HIGH

- As Found: Ask

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4218

- Name: Anti-Inflammatory Agents, Non-Steroidal

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M20786

- Name: Analgesics, Non-Narcotic

- Relevance: LOW

- As Found: Unknown

- ID: M20604

- Name: Antirheumatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M29334

- Name: Phosphodiesterase 4 Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M13629

- Name: Phosphodiesterase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000505730

- Term: Apremilast

### Misc Info Module

- Version Holder: 2024-05-24
