Trial Outcomes & Findings for Study Determining Gastric-Retentive and Modified Release Properties of Prototype Capsules in Healthy Subjects (NCT NCT03468543)

NCT ID: NCT03468543

Last Updated: 2019-06-05

Results Overview

Number of Participants with Gastric Retention by Magnetic Resonance Imaging (MRI), as measured after dosing

• Recruitment status: TERMINATED
• Study phase: EARLY_PHASE1
• Target enrollment: 3 participants
• Primary outcome timeframe: 7 Days
• Results posted on: 2019-06-05

Participant Flow

Participant milestones

Measure	Cohort 1 Subjects will receive an oral administration of 50 mg of Memantine HCl prototype capsule formulation A; then formulation B; following each administration MRI will be performed for up to 14 days Memantine Hydrochloride MR Prototype Capsule Formulation A: Memantine HCl MR capsule formulation will be administered orally in a single dose Memantine Hydrochloride MR Prototype Capsule Formulation B: Memantine HCl MR capsule formulation did NOT get administered Magnetic Resonance Imaging: MRI will be performed on specified days according to protocol
Overall Study STARTED	3
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure

Cohort 1 Subjects will receive an oral administration of 50 mg of Memantine HCl prototype capsule formulation A; then formulation B; following each administration MRI will be performed for up to 14 days Memantine Hydrochloride MR Prototype Capsule Formulation A: Memantine HCl MR capsule formulation will be administered orally in a single dose Memantine Hydrochloride MR Prototype Capsule Formulation B: Memantine HCl MR capsule formulation did NOT get administered Magnetic Resonance Imaging: MRI will be performed on specified days according to protocol

Overall Study Protocol stopping rules met

3

Baseline Characteristics

Study Determining Gastric-Retentive and Modified Release Properties of Prototype Capsules in Healthy Subjects

Baseline characteristics by cohort

Measure	Cohort 1 n=3 Participants Subjects will receive an oral administration of 50 mg of Memantine HCl prototype capsule formulation A; then formulation B; following each administration MRI will be performed for up to 14 days Memantine Hydrochloride MR Prototype Capsule Formulation A: Memantine HCl MR capsule formulation will be administered orally in a single dose Memantine Hydrochloride MR Prototype Capsule Formulation B: Memantine HCl MR capsule formulation will be administered orally in a single dose Magnetic Resonance Imaging: MRI will be performed on specified days according to protocol	Cohort 2 Subjects will receive an oral administration of 50 mg of Memantine HCl prototype capsule formulation C; then formulation D; following each administration MRI will be performed for up to 14 days Memantine Hydrochloride MR Prototype Capsule Formulation C: Memantine HCl MR capsule formulation will be administered orally in a single dose Memantine Hydrochloride MR Prototype Capsule Formulation D: Memantine HCl MR capsule formulation will be administered orally in a single dose Magnetic Resonance Imaging: MRI will be performed on specified days according to protocol	Cohort 3 Subjects will receive an oral administration of 50 mg of Memantine HCl prototype capsule formulation E; followed by MRI for up to 14 days Memantine Hydrochloride MR Prototype Capsule Formulation E: Memantine HCl MR capsule formulation will be administered orally in a single dose Magnetic Resonance Imaging: MRI will be performed on specified days according to protocol	Total n=3 Participants Total of all reporting groups
Age, Continuous	33.7 years STANDARD_DEVIATION 12.3 • n=5 Participants	—	—	33.7 years STANDARD_DEVIATION 12.3 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	—	—	3 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	—	—	1 Participants n=4 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	—	—	2 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Region of Enrollment United Kingdom	3 participants n=5 Participants	—	—	3 participants n=4 Participants

PRIMARY outcome

Timeframe: 7 Days

Population: Subjects who completed dosing and at least one MRI assessment after dosing

Number of Participants with Gastric Retention by Magnetic Resonance Imaging (MRI), as measured after dosing

Outcome measures

Measure

Cohort 1 n=2 Participants Subjects will receive an oral administration of 50 mg of Memantine HCl prototype capsule formulation A; then formulation B; following each administration MRI will be performed for up to 14 days Memantine Hydrochloride MR Prototype Capsule Formulation A: Memantine HCl MR capsule formulation will be administered orally in a single dose Memantine Hydrochloride MR Prototype Capsule Formulation B: Memantine HCl MR capsule formulation will be administered orally in a single dose Magnetic Resonance Imaging: MRI will be performed on specified days according to protocol

Gastric Retention by Magnetic Resonance Imaging (MRI)

2 Participants

Adverse Events

Cohort 1

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure

Cohort 1 n=3 participants at risk Subjects will receive an oral administration of 50 mg of Memantine HCl prototype capsule formulation A; then formulation B; following each administration MRI will be performed for up to 14 days Memantine Hydrochloride MR Prototype Capsule Formulation A: Memantine HCl MR capsule formulation will be administered orally in a single dose Memantine Hydrochloride MR Prototype Capsule Formulation B: Memantine HCl MR capsule formulation was NOT administered Magnetic Resonance Imaging: MRI will be performed on specified days according to protocol

Injury, poisoning and procedural complications foreign body

33.3% 1/3 • Number of events 1 • Adverse events were collected for five weeks after each dose of study drug. Additional information: Adverse events were collected for five weeks after each dose of study drug in Cohort 1 only. Cohorts 2 and 3 were not performed as the study was stopped, therefore the number of participants at risk for AE's (all types) is zero.

Other adverse events

Measure	Cohort 1 n=3 participants at risk Subjects will receive an oral administration of 50 mg of Memantine HCl prototype capsule formulation A; then formulation B; following each administration MRI will be performed for up to 14 days Memantine Hydrochloride MR Prototype Capsule Formulation A: Memantine HCl MR capsule formulation will be administered orally in a single dose Memantine Hydrochloride MR Prototype Capsule Formulation B: Memantine HCl MR capsule formulation was NOT administered Magnetic Resonance Imaging: MRI will be performed on specified days according to protocol
Nervous system disorders presyncope	33.3% 1/3 • Number of events 1 • Adverse events were collected for five weeks after each dose of study drug. Additional information: Adverse events were collected for five weeks after each dose of study drug in Cohort 1 only. Cohorts 2 and 3 were not performed as the study was stopped, therefore the number of participants at risk for AE's (all types) is zero.
General disorders crying	33.3% 1/3 • Number of events 1 • Adverse events were collected for five weeks after each dose of study drug. Additional information: Adverse events were collected for five weeks after each dose of study drug in Cohort 1 only. Cohorts 2 and 3 were not performed as the study was stopped, therefore the number of participants at risk for AE's (all types) is zero.
General disorders non-cardiac chest pain	33.3% 1/3 • Number of events 1 • Adverse events were collected for five weeks after each dose of study drug. Additional information: Adverse events were collected for five weeks after each dose of study drug in Cohort 1 only. Cohorts 2 and 3 were not performed as the study was stopped, therefore the number of participants at risk for AE's (all types) is zero.
Psychiatric disorders anxiety	33.3% 1/3 • Number of events 1 • Adverse events were collected for five weeks after each dose of study drug. Additional information: Adverse events were collected for five weeks after each dose of study drug in Cohort 1 only. Cohorts 2 and 3 were not performed as the study was stopped, therefore the number of participants at risk for AE's (all types) is zero.
Gastrointestinal disorders abdominal discomfort	33.3% 1/3 • Number of events 1 • Adverse events were collected for five weeks after each dose of study drug. Additional information: Adverse events were collected for five weeks after each dose of study drug in Cohort 1 only. Cohorts 2 and 3 were not performed as the study was stopped, therefore the number of participants at risk for AE's (all types) is zero.
Gastrointestinal disorders abdominal pain	33.3% 1/3 • Number of events 4 • Adverse events were collected for five weeks after each dose of study drug. Additional information: Adverse events were collected for five weeks after each dose of study drug in Cohort 1 only. Cohorts 2 and 3 were not performed as the study was stopped, therefore the number of participants at risk for AE's (all types) is zero.
Gastrointestinal disorders dysphagia	33.3% 1/3 • Number of events 1 • Adverse events were collected for five weeks after each dose of study drug. Additional information: Adverse events were collected for five weeks after each dose of study drug in Cohort 1 only. Cohorts 2 and 3 were not performed as the study was stopped, therefore the number of participants at risk for AE's (all types) is zero.
Gastrointestinal disorders nausea	33.3% 1/3 • Number of events 1 • Adverse events were collected for five weeks after each dose of study drug. Additional information: Adverse events were collected for five weeks after each dose of study drug in Cohort 1 only. Cohorts 2 and 3 were not performed as the study was stopped, therefore the number of participants at risk for AE's (all types) is zero.
Gastrointestinal disorders vomiting	33.3% 1/3 • Number of events 1 • Adverse events were collected for five weeks after each dose of study drug. Additional information: Adverse events were collected for five weeks after each dose of study drug in Cohort 1 only. Cohorts 2 and 3 were not performed as the study was stopped, therefore the number of participants at risk for AE's (all types) is zero.

Additional Information

Andrew Bellinger, MD, PhD

Lyndra

Phone: 857-302-7878

Email: abellinger@lyndra.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER