Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Memantine HCl and Donepezil HCl Extended Release Capsules in Healthy Volunteers

Phase 1, Open-Label Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Memantine HCl and Donepezil HCl Extended Release Capsules in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619000571178

Enrollment

Registered

2019-04-11

Start date

2019-04-26

Completion date

2019-05-06

Last updated

2019-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

To assess the pharmacokinetics of memantine and donepezil in LYN-157 extended release capsules. To evaluate the safety of LYN-157 extended release capsules containing memantine HCl and donepezil HCl in healthy volunteers

Interventions

The intervention is LYN-157, a extended release (ER) prototype capsule containing memantine hydrochloride (HCl) (40 mg) and donepezil HCl (38 mg). The rationale for the development of this ER formulation is to reduce the frequency of dosing orally administered memantine and donepezil HCl medications to once weekly or less and thereby improving the management of Alzheimer's disease. The dose of LYN-157 to be given is a single Size 00EL capsule containing 40 mg memantine HCl and 38 mg donepezil HCl within the ER formulation (stellate). One capsule will be administered to the participant. This single capsule dose will be administered by a trained nurse (at a minimum) in a clinic for both Sentinel and Main, if required, dropouts will be replaced at the discretion of the PI.

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

1) Healthy male and female participants 2) Body mass index of 18.0 to 30.0 kg/meters-squared 3) Suitable score for swallowing questionnaire 4) Demonstrate normal swallowing and gastrointestinal passage for capsules, as assessed while undergoing imaging studies 5) Must provide written informed consent

Exclusion criteria

1) History of any drug or alcohol abuse in past 2 years 2) Current smokers and those who have smoked within the past 12 months 3) Individuals with clinically significant medical history related to the gastrointestinal tract and potential complications, thereof 4) Individuals with a positive test for HIV, hepatitis B or hepatitis C 5) Individuals who are contraindicated based on either memantine HCl or donepezil HCl 6) Serious adverse reaction or serious hypersensitivity to components of the study formulation or patency capsule 7) Individuals who have received any experimental agent within 30 days (or 5 half-lives), whichever is longer, prior to the date of dosing 8) Individuals with contraindication to MRI imaging 9) Individuals with functional constipation, irritable bowl or functional diarrhoea 10) Individuals with contraindications to elective X-ray based on known or expected radiation exposure

Outcome results