A Study of Lasmiditan in Healthy Volunteers

NCT04749914 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 17573H8H-MC-LAIO
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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

Keywords

Drug Interaction Study

Outcome Measures

Primary Outcomes (4)

• Part 1 Pharmacokinetics (PK): Maximum Concentration (Cmax) of Dabigatran to Assess P-glycoprotein (P-gp) Activity.

  PK: Cmax of Dabigatran.

  Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours post-dose.

• Part 2 PK: Cmax of Rosuvastatin to Assess Breast Cancer Resistance Protein (BCRP) Activity.

  PK: Cmax of Rosuvastatin.

  Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 hours post-dose.

• Part 1 PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞] ) of Dabigatran to Assess P-gp Activity.

  PK: AUC\[0-∞\] of Dabigatran

  Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours post-dose.

• Part 2 PK: AUC[0-∞] of Rosuvastatin to Assess BCRP Activity.

  PK: AUC\[0-∞\] of Rosuvastatin

  Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 hours post-dose.

Study Arms (2)

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

EXPERIMENTAL

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

Drug: Lasmiditan; Drug: Dabigatran Etexilate

10 mg Rosuvastatin + 200 mg Lasmiditan - Part 2

EXPERIMENTAL

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.

Drug: Lasmiditan; Drug: Rosuvastatin

Interventions

Lasmiditan DRUG

Administered orally.

Also known as: LY573144

10 mg Rosuvastatin + 200 mg Lasmiditan - Part 2; 150 Milligram (mg) Dabigatran Etexilate + 200mg Lasmiditan - Part 1

Dabigatran Etexilate DRUG

Administered orally.

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

Rosuvastatin DRUG

Administered orally.

10 mg Rosuvastatin + 200 mg Lasmiditan - Part 2

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

Location

MeSH Terms

Interventions

lasmiditan; Dabigatran; Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 11, 2021
• Study Start: February 15, 2021
• Primary Completion: July 6, 2021
• Study Completion: July 6, 2021
• Last Updated: February 1, 2024
• Results First Posted: February 1, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share

Locations

SG (1)