A Study of Lasmiditan in Healthy Volunteers

NCT ID: NCT04749914

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-15
• Study Completion Date: 2021-07-06

Brief Summary

The main purpose of the study is to investigate the blood concentrations of dabigatran etexilate and rosuvastatin when taken alone compared to when taken together with lasmiditan in healthy participants. The safety and tolerability of dabigatran etexilate or rosuvastatin in combination with lasmiditan will also be evaluated in healthy participants. The study has two parts. Each part will last up to 17 days, not including screening.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

150 Milligram (mg) Dabigatran Etexilate + 200mg Lasmiditan - Part 1

Participants received 150 mg dabigatran etexilate on Day 1 followed by 200 mg lasmiditan once daily (QD) on Days 8 and 9, and 150 mg of dabigatran etexilate along with 200 mg lasmiditan on Day 10. All treatments were administered orally

Group Type: EXPERIMENTAL

Lasmiditan

Intervention Type: DRUG

Administered orally.

Dabigatran Etexilate

Intervention Type: DRUG

Administered orally.

10 mg Rosuvastatin + 200 mg Lasmiditan - Part 2

Participants received 10 mg rosuvastatin on Day 1 followed by 200 mg lasmiditan QD on Days 8 and 9, and 10 mg of rosuvastatin along with 200 mg lasmiditan on Day 10. All treatments were administered orally.

Group Type: EXPERIMENTAL

Lasmiditan

Intervention Type: DRUG

Administered orally.

Rosuvastatin

Intervention Type: DRUG

Administered orally.

Interventions

Lasmiditan

Administered orally.

Intervention Type: DRUG

Dabigatran Etexilate

Administered orally.

Intervention Type: DRUG

Rosuvastatin

Administered orally.

Intervention Type: DRUG

Other Intervention Names

LY573144

Eligibility Criteria

Inclusion Criteria

• Are overtly healthy
• Body mass index (BMI) of 18.5 to 35 kilograms per meter squared (kg/m²)

Exclusion Criteria

• have known allergies to lasmiditan, dabigatran, rosuvastatin-related compounds or any components of the formulation of lasmiditan, dabigatran, rosuvastatin, or a history of significant atopy
• have an abnormal blood pressure and/or pulse rate as determined by the investigator
• have clinically significant abnormalities on electrocardiogram (ECG) as determined by investigator
• have a history or presence of cardiovascular, respiratory, 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 interventions; or of interfering with the interpretation of data. Appendectomy, splenectomy, and cholecystectomy are considered as acceptable
• have any medical conditions, medical history, or are taking any medications that are contraindicated in the dabigatran etexilate or rosuvastatin label
• are intending to use over-the-counter or prescription medication, including dietary supplements, traditional medicines, and herbal supplements, within 14 days prior to dosing and until study discharge (apart from occasional acetaminophen, hormonal contraception, or hormone replacement therapy)
• currently use or show evidence of substance abuse (including alcohol abuse) or dependence within the past 6 months based on history at screening
• Part 1 Only: have known bleeding disorder including prior personal or familial history of abnormal bleeding, hereditary or acquired coagulation or platelet disorder or abnormal coagulation test (prothrombin time/international normalized ratio [INR] or partial thromboplastin time/activated partial thromboplastin time greater than upper limit of normal [ULN]) result at screening
• Part 2 only: have c.34AA, c.421AA, or c.34GA/421CA genotypes of ABCG2 as determined through genotyping

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Eli Lilly and Company

Locations

Lilly Centre for Clinical Pharmacology

Singapore, , Singapore

Countries

Singapore

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

H8H-MC-LAIO

Identifier Type: OTHER

Identifier Source: secondary_id

17573

Identifier Type: -

Identifier Source: org_study_id