Gastric RetentionEarly Phase 1NCT03468543
Study Determining Gastric-Retentive and Modified Release Properties of Prototype Capsules in Healthy Subjects
A Early Phase 1 study testing Memantine Hydrochloride MR Prototype Capsule Formulation A, Memantine Hydrochloride MR Prototype Capsule Formulation B and Memantine Hydrochloride MR Prototype Capsule Formulation C in people with Gastric Retention and Healthy, run by Lyndra Inc. at 1 site in United Kingdom.
Trial summary
To assess how long modified release (MR) memantine hydrochloride prototype capsule formulations stay in the stomach as determined by magnetic resonance imaging (MRI). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Retention, Healthy
- What is being tested?
- Memantine Hydrochloride MR Prototype Capsule Formulation A, Memantine Hydrochloride MR Prototype Capsule Formulation B and Memantine Hydrochloride MR Prototype Capsule Formulation C
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Jul 2017to 18 Sep 2017
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects.
- Body mass index of 18.0 to 32.0 kg/m2.
- Subjects must demonstrate their ability to swallow a test capsule at screening.
- Must provide written informed consent.
Who cannot join
- Subjects who have received any investigational medicinal product in a clinical research study within the previous 3 months.
- Subjects who have previously been enrolled in this study.
- History of any drug or alcohol abuse in the past 2 years.
- Current smokers and those who have smoked within the last 12 months.
- Individuals with clinically significant medical history relating to the gastrointestinal tract and potential for complications, thereof
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results.
Show all 9Show fewer
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
- Individuals with contraindication to MRI imaging.
- Other protocol defined criteria may apply.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Sciences (formerly Quotient Clinical)
Ruddington, Nottingham, NG11 6JS
About this study
Official title: A Study Designed to Determine the Gastro-Retentive and Modified Release Properties of Memantine Hydrochloride (HCl) Prototype Capsule Formulations in Healthy Subjects
To assess how long modified release (MR) memantine hydrochloride prototype capsule formulations stay in the stomach as determined by magnetic resonance imaging (MRI).
Read the detailed description
This is a single center, open-label, single dose, 5-period study in 24 healthy male and female subjects, with an optional Period 6, if required. It is expected the study will be executed in 3 cohorts of 8 subjects, with each cohort participating in up to 2 study periods (total of up to 6 study periods). Cohort 3 may be conducted in parallel with Cohort 2.
Subjects will be dosed in a sequential manner, as appropriate. Each subject will be administered up to 2 regimens (2 different prototype capsule formulations) across 2 study periods. There will be a minimum 35-day interval between each dose administration.
Subjects will have an MRI scan performed on Days 2, 4, 7, 10 and 14 of each period to assess the gastric retentive properties of the formulation.
- Conditions
- Gastric Retention, Healthy
- Being tested
- Memantine Hydrochloride MR Prototype Capsule Formulation A, Memantine Hydrochloride MR Prototype Capsule Formulation B, Memantine Hydrochloride MR Prototype Capsule Formulation C, Memantine Hydrochloride MR Prototype Capsule Formulation D, Memantine Hydrochloride MR Prototype Capsule Formulation E
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Memantine Hydrochloride MR Prototype Capsule Formulation ADrug
Also called Memantine HCl Capsule Formulation A (50 mg)
Memantine HCl MR capsule formulation will be administered orally in a single dose
Memantine Hydrochloride MR Prototype Capsule Formulation BDrug
Also called Memantine HCl Capsule Formulation B (50 mg)
Memantine HCl MR capsule formulation will be administered orally in a single dose
Memantine Hydrochloride MR Prototype Capsule Formulation CDrug
Also called Memantine HCl Capsule Formulation C (50 mg)
Memantine HCl MR capsule formulation will be administered orally in a single dose
Memantine Hydrochloride MR Prototype Capsule Formulation DDrug
Also called Memantine HCl Capsule Formulation D (50 mg)
Memantine HCl MR capsule formulation will be administered orally in a single dose
Memantine Hydrochloride MR Prototype Capsule Formulation EDrug
Also called Memantine HCl Capsule Formulation E (50 mg)
Memantine HCl MR capsule formulation will be administered orally in a single dose
Magnetic Resonance ImagingProcedure or surgery
Also called MRI
MRI will be performed on specified days according to protocol
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 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 Receives: Drug: Memantine Hydrochloride MR Prototype Capsule Formulation A; Drug: Memantine Hydrochloride MR Prototype Capsule Formulation B; Procedure: Magnetic Resonance Imaging |
| Cohort 2 | Experimental | 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 Receives: Drug: Memantine Hydrochloride MR Prototype Capsule Formulation C; Drug: Memantine Hydrochloride MR Prototype Capsule Formulation D; Procedure: Magnetic Resonance Imaging |
| Cohort 3 | Experimental | Subjects will receive an oral administration of 50 mg of Memantine HCl prototype capsule formulation E; followed by MRI for up to 14 days Receives: Drug: Memantine Hydrochloride MR Prototype Capsule Formulation E; Procedure: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric Retention by Magnetic Resonance Imaging (MRI)
Number of Participants with Gastric Retention by Magnetic Resonance Imaging (MRI), as measured after dosing
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start26 Jul 2017
- Primary completion18 Sep 2017
- Study completion18 Sep 2017
Why it stopped: Per protocol stopping rules
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastric RetentionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lyndra Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stuart Mair, MBChB, DRCOG, Study director, Quotient Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468543
- Sponsor's protocol ID
- QCL117924
- Other IDs
- 2017-000982-61, 2017
- Status last verified
- Aug 2018
- First submitted
- 5 Mar 2018
- Last updated
- 5 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Designed to Determine the Gastro-Retentive and Modified Release Properties of Memantine Hydrochloride (HCl) Prototype Capsule Formulations in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03468543
- Acronym / sponsor ID
- QCL117924
- Conditions
- Gastric Retention, Healthy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Per protocol stopping rules
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Lyndra Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Jul 2017 (actual)
- Primary completion
- 18 Sep 2017 (actual)
- Study completion
- 18 Sep 2017 (actual)
- First posted
- 16 Mar 2018 (actual)
- Results
- Posted 5 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess how long modified release (MR) memantine hydrochloride prototype capsule formulations stay in the stomach as determined by magnetic resonance imaging (MRI).
Detailed description
This is a single center, open-label, single dose, 5-period study in 24 healthy male and female subjects, with an optional Period 6, if required. It is expected the study will be executed in 3 cohorts of 8 subjects, with each cohort participating in up to 2 study periods (total of up to 6 study periods). Cohort 3 may be conducted in parallel with Cohort 2.
Subjects will be dosed in a sequential manner, as appropriate. Each subject will be administered up to 2 regimens (2 different prototype capsule formulations) across 2 study periods. There will be a minimum 35-day interval between each dose administration.
Subjects will have an MRI scan performed on Days 2, 4, 7, 10 and 14 of each period to assess the gastric retentive properties of the formulation.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Memantine Hydrochloride MR Prototype Capsule Formulation A, Drug: Memantine Hydrochloride MR Prototype Capsule Formulation B, Procedure: Magnetic Resonance ImagingSubjects 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 |
| Cohort 2 | Experimental | Drug: Memantine Hydrochloride MR Prototype Capsule Formulation C, Drug: Memantine Hydrochloride MR Prototype Capsule Formulation D, Procedure: Magnetic Resonance ImagingSubjects 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 |
| Cohort 3 | Experimental | Drug: Memantine Hydrochloride MR Prototype Capsule Formulation E, Procedure: Magnetic Resonance ImagingSubjects will receive an oral administration of 50 mg of Memantine HCl prototype capsule formulation E; followed by MRI for up to 14 days |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and female subjects.
- Body mass index of 18.0 to 32.0 kg/m2.
- Subjects must demonstrate their ability to swallow a test capsule at screening.
- Must provide written informed consent.
Key exclusion criteria (9 listed)
- Subjects who have received any investigational medicinal product in a clinical research study within the previous 3 months.
- Subjects who have previously been enrolled in this study.
- History of any drug or alcohol abuse in the past 2 years.
- Current smokers and those who have smoked within the last 12 months.
- Individuals with clinically significant medical history relating to the gastrointestinal tract and potential for complications, thereof
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Memantine Hydrochloride MR Prototype Capsule Formulation AAlso: Memantine HCl Capsule Formulation A (50 mg)Memantine HCl MR capsule formulation will be administered orally in a single dose | Drug | Cohort 1 |
| Memantine Hydrochloride MR Prototype Capsule Formulation BAlso: Memantine HCl Capsule Formulation B (50 mg)Memantine HCl MR capsule formulation will be administered orally in a single dose | Drug | Cohort 1 |
| Memantine Hydrochloride MR Prototype Capsule Formulation CAlso: Memantine HCl Capsule Formulation C (50 mg)Memantine HCl MR capsule formulation will be administered orally in a single dose | Drug | Cohort 2 |
| Memantine Hydrochloride MR Prototype Capsule Formulation DAlso: Memantine HCl Capsule Formulation D (50 mg)Memantine HCl MR capsule formulation will be administered orally in a single dose | Drug | Cohort 2 |
| Memantine Hydrochloride MR Prototype Capsule Formulation EAlso: Memantine HCl Capsule Formulation E (50 mg)Memantine HCl MR capsule formulation will be administered orally in a single dose | Drug | Cohort 3 |
| Magnetic Resonance ImagingAlso: MRIMRI will be performed on specified days according to protocol | Procedure or surgery | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Gastric Retention by Magnetic Resonance Imaging (MRI)
Time frame: 7 Days
Number of Participants with Gastric Retention by Magnetic Resonance Imaging (MRI), as measured after dosing
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart Mair, MBChB, DRCOG study director
Quotient Clinical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Memantine Hydrochloride MR Prototype Capsule Formulation A, Memantine Hydrochloride MR Prototype Capsule Formulation B and Memantine Hydrochloride MR Prototype Capsule Formulation C in people with Gastric Retention and Healthy, run by Lyndra Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric Retention by Magnetic Resonance Imaging (MRI) (time frame: 7 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2019.