Trial Outcomes & Findings for Study of Oral Lasmiditan in Participants With Normal and Impaired Renal Function (NCT NCT03009162)

NCT ID: NCT03009162

Last Updated: 2019-12-02

Results Overview

Maximum observed plasma concentration of lasmiditan.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 16 participants
• Primary outcome timeframe: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours, postdose
• Results posted on: 2019-12-02

Participant Flow

Participant milestones

Measure	Healthy Participants Participants received single 200 milligrams (mg) oral dose of lasmiditan.	Renal Impaired Participants Participants received single 200 mg oral dose of lasmiditan.
Overall Study STARTED	8	8
Overall Study Received at Least 1 Dose of Study Drug	8	8
Overall Study COMPLETED	8	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Oral Lasmiditan in Participants With Normal and Impaired Renal Function

Baseline characteristics by cohort

Measure	Healthy Participants n=8 Participants Participants received single 200 milligrams (mg) oral dose of lasmiditan.	Renal Impaired Participants n=8 Participants Participants received single 200 mg oral dose of lasmiditan.	Total n=16 Participants Total of all reporting groups
Age, Continuous	45.4 Years STANDARD_DEVIATION 12.3 • n=5 Participants	51.8 Years STANDARD_DEVIATION 15.6 • n=7 Participants	48.6 Years STANDARD_DEVIATION 14.0 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Canada	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours, postdose

Population: All enrolled participants who received at least one dose of study drug and have evaluable pharmacokinetics (PK) data.

Maximum observed plasma concentration of lasmiditan.

Outcome measures

Measure	Healthy Participants n=8 Participants Participants received single 200 mg oral dose of lasmiditan.	Renal Impaired Participants n=8 Participants Participants received single 200 mg oral dose of lasmiditan.
Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax)	259 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 44	293 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 35

PRIMARY outcome

Timeframe: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours, postdose

Population: All enrolled participants who received at least one dose of study drug and have evaluable PK data.

Time of maximum observed plasma concentration; if it occurs at more than one time point, Tmax is defined as the first time point with this value

Outcome measures

Measure	Healthy Participants n=8 Participants Participants received single 200 mg oral dose of lasmiditan.	Renal Impaired Participants n=8 Participants Participants received single 200 mg oral dose of lasmiditan.
Pharmacokinetics: Time of Maximum Observed Plasma Concentration (Tmax)	2.50 hours (h) Interval 1.0 to 3.0	1.78 hours (h) Interval 0.75 to 3.0

PRIMARY outcome

Timeframe: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours, postdose

Population: All enrolled participants who received at least one dose of study drug and have evaluable PK data.

Area Under the Concentration Versus Time Curve (AUC) from time zero to tlast (AUC[0- tlast]) of lasmiditan.

Outcome measures

Measure	Healthy Participants n=8 Participants Participants received single 200 mg oral dose of lasmiditan.	Renal Impaired Participants n=8 Participants Participants received single 200 mg oral dose of lasmiditan.
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Tlast (AUC[0-tlast])	1580 nanogram*hour per milliliter (ng*h/mL) Geometric Coefficient of Variation 44	1870 nanogram*hour per milliliter (ng*h/mL) Geometric Coefficient of Variation 32

PRIMARY outcome

Timeframe: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours, postdose

Population: All enrolled participants who received at least one dose of study drug and have evaluable PK data.

Area Under the Concentration Versus Time Curve (AUC) from time zero to infinity (AUC[0-inf]) of lasmiditan.

Outcome measures

Measure	Healthy Participants n=8 Participants Participants received single 200 mg oral dose of lasmiditan.	Renal Impaired Participants n=8 Participants Participants received single 200 mg oral dose of lasmiditan.
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf])	1600 ng*h/mL Geometric Coefficient of Variation 44	1890 ng*h/mL Geometric Coefficient of Variation 32

PRIMARY outcome

Timeframe: Predose and intervals: 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24 and 24 to 36 hours, postdose

Population: All enrolled participants who received at least one dose of study drug and have evaluable PK data.

Amount excreted in urine (calculated as total lasmiditan concentration multiplied by volume of urine)

Outcome measures

Measure	Healthy Participants n=8 Participants Participants received single 200 mg oral dose of lasmiditan.	Renal Impaired Participants n=8 Participants Participants received single 200 mg oral dose of lasmiditan.
Pharmacokinetics: Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae [0-t])	4.64 milligrams (mg) Geometric Coefficient of Variation 36	1.85 milligrams (mg) Geometric Coefficient of Variation 45

PRIMARY outcome

Timeframe: Predose and intervals: 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24 and 24 to 36 hours, postdose

Population: All enrolled participants who received at least one dose of study drug and have evaluable PK data.

Fraction of dose excreted in urine (Ae / dose)

Outcome measures

Measure	Healthy Participants n=8 Participants Participants received single 200 mg oral dose of lasmiditan.	Renal Impaired Participants n=8 Participants Participants received single 200 mg oral dose of lasmiditan.
Pharmacokinetics: Fraction of Dose Excreted in Urine (fe)	2.32 Percentage Geometric Coefficient of Variation 36	0.93 Percentage Geometric Coefficient of Variation 45

PRIMARY outcome

Timeframe: Predose and intervals: 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24 and 24 to 36 hours, postdose

Population: All enrolled participants who received at least one dose of study drug and have evaluable PK data.

Renal Clearance is the volume of blood or plasma that is completely cleared of the drug by the kidneys per unit time. (Ae(0-t)/AUC0-T)

Outcome measures

Measure	Healthy Participants n=8 Participants Participants received single 200 mg oral dose of lasmiditan.	Renal Impaired Participants n=8 Participants Participants received single 200 mg oral dose of lasmiditan.
Pharmacokinetics: Renal Clearance (CLr)	2.93 Liters/hour (L/h) Geometric Coefficient of Variation 28	0.992 Liters/hour (L/h) Geometric Coefficient of Variation 42

SECONDARY outcome

Timeframe: Up To 7 days

Population: All enrolled participants who received at least one dose of study drug.

Safety was assessed from time of consent through end of study (up to 7 days). Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs). A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this record.

Outcome measures

Measure	Healthy Participants n=8 Participants Participants received single 200 mg oral dose of lasmiditan.	Renal Impaired Participants n=8 Participants Participants received single 200 mg oral dose of lasmiditan.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Other AEs	6 Participants	6 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	0 Participants	0 Participants

Adverse Events

Healthy Participants

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Renal Impaired Participants

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Healthy Participants n=8 participants at risk Participants received single 200 mg oral dose of lasmiditan.	Renal Impaired Participants n=8 participants at risk Participants received single 200 mg oral dose of lasmiditan.
Gastrointestinal disorders Nausea	25.0% 2/8 • Number of events 2 • Up To 7 days All enrolled participants who received at least one dose of study drug.	0.00% 0/8 • Up To 7 days All enrolled participants who received at least one dose of study drug.
General disorders Fatigue	0.00% 0/8 • Up To 7 days All enrolled participants who received at least one dose of study drug.	37.5% 3/8 • Number of events 3 • Up To 7 days All enrolled participants who received at least one dose of study drug.
General disorders Feeling abnormal	12.5% 1/8 • Number of events 1 • Up To 7 days All enrolled participants who received at least one dose of study drug.	0.00% 0/8 • Up To 7 days All enrolled participants who received at least one dose of study drug.
General disorders Vessel puncture site bruise	12.5% 1/8 • Number of events 1 • Up To 7 days All enrolled participants who received at least one dose of study drug.	0.00% 0/8 • Up To 7 days All enrolled participants who received at least one dose of study drug.
General disorders Vessel puncture site erythema	12.5% 1/8 • Number of events 1 • Up To 7 days All enrolled participants who received at least one dose of study drug.	0.00% 0/8 • Up To 7 days All enrolled participants who received at least one dose of study drug.
General disorders Vessel puncture site pain	12.5% 1/8 • Number of events 1 • Up To 7 days All enrolled participants who received at least one dose of study drug.	0.00% 0/8 • Up To 7 days All enrolled participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Foreign body in respiratory tract	12.5% 1/8 • Number of events 1 • Up To 7 days All enrolled participants who received at least one dose of study drug.	0.00% 0/8 • Up To 7 days All enrolled participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Procedural anxiety	12.5% 1/8 • Number of events 1 • Up To 7 days All enrolled participants who received at least one dose of study drug.	0.00% 0/8 • Up To 7 days All enrolled participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Scratch	12.5% 1/8 • Number of events 1 • Up To 7 days All enrolled participants who received at least one dose of study drug.	0.00% 0/8 • Up To 7 days All enrolled participants who received at least one dose of study drug.
Nervous system disorders Dizziness	37.5% 3/8 • Number of events 3 • Up To 7 days All enrolled participants who received at least one dose of study drug.	12.5% 1/8 • Number of events 1 • Up To 7 days All enrolled participants who received at least one dose of study drug.
Nervous system disorders Headache	25.0% 2/8 • Number of events 2 • Up To 7 days All enrolled participants who received at least one dose of study drug.	0.00% 0/8 • Up To 7 days All enrolled participants who received at least one dose of study drug.
Nervous system disorders Hypoaesthesia	0.00% 0/8 • Up To 7 days All enrolled participants who received at least one dose of study drug.	25.0% 2/8 • Number of events 2 • Up To 7 days All enrolled participants who received at least one dose of study drug.
Nervous system disorders Lethargy	0.00% 0/8 • Up To 7 days All enrolled participants who received at least one dose of study drug.	12.5% 1/8 • Number of events 1 • Up To 7 days All enrolled participants who received at least one dose of study drug.
Nervous system disorders Paraesthesia	0.00% 0/8 • Up To 7 days All enrolled participants who received at least one dose of study drug.	25.0% 2/8 • Number of events 2 • Up To 7 days All enrolled participants who received at least one dose of study drug.
Nervous system disorders Somnolence	37.5% 3/8 • Number of events 3 • Up To 7 days All enrolled participants who received at least one dose of study drug.	25.0% 2/8 • Number of events 2 • Up To 7 days All enrolled participants who received at least one dose of study drug.
Nervous system disorders Tremor	0.00% 0/8 • Up To 7 days All enrolled participants who received at least one dose of study drug.	12.5% 1/8 • Number of events 1 • Up To 7 days All enrolled participants who received at least one dose of study drug.
Vascular disorders Orthostatic hypotension	0.00% 0/8 • Up To 7 days All enrolled participants who received at least one dose of study drug.	25.0% 2/8 • Number of events 2 • Up To 7 days All enrolled participants who received at least one dose of study drug.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: ClinicalTrials.gov@lilly.com

Results disclosure agreements

• Principal investigator is a sponsor employee Details of the Study and its results shall not be publicized in any form without prior consent of the Sponsor. Such approval is necessary to prevent premature disclosure of trade secrets and other confidential information.
• Publication restrictions are in place

Restriction type: OTHER