Healthy SubjectsPhase 1NCT04849286
Measurement of HTL0016878 in Cerebrospinal Fluid
A Phase 1 study testing HTL0016878 in people with Healthy Subjects, run by Nxera Pharma UK Limited at 1 site in United Kingdom.
Trial summary
A Phase 1, open-label, randomised, single oral dose study to determine the concentration of HTL0016878 in CSF and plasma in healthy male subjects following dosing with HTL0016878 10 mg or 20 mg oral solution Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- HTL0016878
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Sep 2018to 7 Dec 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject has a body mass index (BMI) of 18 to 32 kg/m2, inclusive. Healthy as determined by a responsible physician, based on medical evaluation including medical history, physical examination, concomitant medication, vital signs, 12-lead ECG, C-SSRS responses, and clinical laboratory evaluations.
- Willingness to comply with requirements or the trial, including contraception requirements.
- Able to give fully informed consent.
Who cannot join
- Positive tests for hepatitis B \& C, HIV. Clinically relevant history of abnormal physical or mental health. Clinically relevant abnormal laboratory results (including hepatic and renal panels, complete blood count, chemistry or coagulation panel and urinalysis), 12-lead ECG and vital signs, or physical findings.
- History of severe adverse reactions or allergies, or history of an anaphylactic reaction to prescription or non-prescription medication or food.
- Drug or alcohol abuse. Smoking. Use of medication that inhibits CYP2D6. Participation in other clinical trials of unlicensed medicines in the previous 3 months. Loss of more than 400 mL blood in the previous 3 months. Vital signs, QTcF interval or laboratory values outside the acceptable range. Predicted poor and intermediate CYP2D6 metabolisers. Clinically relevant abnormal findings at the screening assessment. History of epilepsy or seizures. Clinically relevant abnormal medical history or concurrent medical condition disease associated with cognitive impairment and/or psychosis. History of suicidal thoughts or ideation, or any history of insomnia. Use of tobacco and/or nicotine containing products within 90 days of dosing. Habitual and heavy consumption of caffeinated beverages. Consumption of cranberry, pomegranate, star fruit, grapefruit, pomelos, exotic citrus fruits or Seville oranges (including marmalade and juices made from these fruits) within 3 days before admission. Objection by General Practitioner
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Randomised, Single-centre, Single Oral Dose Study to Determine the Concentration of HTL0016878 in Cerebrospinal Fluid and Plasma in Healthy Male Subjects Following Dosing With HTL0016878 Oral Solution
A Phase 1, open-label, randomised, single oral dose study to determine the concentration of HTL0016878 in CSF and plasma in healthy male subjects following dosing with HTL0016878 10 mg or 20 mg oral solution
Read the detailed description
Up to 24 healthy subjects will be enrolled into 4 groups, with 6 subjects per group. Each subject will be randomised to receive a single oral dose of 10 mg or 20 mg HTL0016878 solution and will have a single CSF sample taken via lumbar puncture at either 2 or 6 hours post-dose. Pharmacokinetic blood sampling and safety measures will continue until 24 hours post-dose.
- Conditions
- Healthy Subjects
- Being tested
- HTL0016878
- Keywords
- Cerebrospinal Fluid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTL0016878Drug
Oral solution
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 10 mg dose, CSF sample 2 hours post-dose Receives: Drug: HTL0016878 |
| Group 2 | Experimental | 10 mg dose, CSF sample 6 hours post-dose Receives: Drug: HTL0016878 |
| Group 3 | Experimental | 20 mg dose, CSF sample 2 hours post-dose Receives: Drug: HTL0016878 |
| Group 4 | Experimental | 20 mg dose, CSF sample 6 hours post-dose Receives: Drug: HTL0016878 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of HTL0016878 in CSF
Pharmacokinetics
Measured: 2 hours
Concentration of HTL0016878 in CSF
Pharmacokinetics
Measured: 6 hours
Concentration of HTL0016878 in plasma Cmax
Pharmacokinetics
Measured: 0-24 hours
Concentration of HTL0016878 in plasma AUC
Pharmacokinetics
Measured: 0-24 hours
Secondary outcomes (1)
Treatment Emergent Adverse events
Safety and Tolerability
Measured: Baseline up to 10 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start26 Sep 2018
- Primary completion7 Dec 2018
- Study completion7 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nxera Pharma UK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04849286
- Sponsor's protocol ID
- HTL0016878-103
- Other IDs
- 2018-002784-26, 2018
- Status last verified
- Apr 2021
- First submitted
- 15 Apr 2021
- Last updated
- 19 Apr 2021
- Results posted
- No
- 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 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Randomised, Single-centre, Single Oral Dose Study to Determine the Concentration of HTL0016878 in Cerebrospinal Fluid and Plasma in Healthy Male Subjects Following Dosing With HTL0016878 Oral Solution
- ClinicalTrials.gov ID
- NCT04849286
- Acronym / sponsor ID
- HTL0016878-103
- Conditions
- Healthy Subjects
- Keywords
- Cerebrospinal Fluid
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Nxera Pharma UK LimitedIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- 7 Dec 2018 (actual)
- Study completion
- 7 Dec 2018 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 1, open-label, randomised, single oral dose study to determine the concentration of HTL0016878 in CSF and plasma in healthy male subjects following dosing with HTL0016878 10 mg or 20 mg oral solution
Detailed description
Up to 24 healthy subjects will be enrolled into 4 groups, with 6 subjects per group. Each subject will be randomised to receive a single oral dose of 10 mg or 20 mg HTL0016878 solution and will have a single CSF sample taken via lumbar puncture at either 2 or 6 hours post-dose. Pharmacokinetic blood sampling and safety measures will continue until 24 hours post-dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: HTL001687810 mg dose, CSF sample 2 hours post-dose |
| Group 2 | Experimental | Drug: HTL001687810 mg dose, CSF sample 6 hours post-dose |
| Group 3 | Experimental | Drug: HTL001687820 mg dose, CSF sample 2 hours post-dose |
| Group 4 | Experimental | Drug: HTL001687820 mg dose, CSF sample 6 hours post-dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subject has a body mass index (BMI) of 18 to 32 kg/m2, inclusive. Healthy as determined by a responsible physician, based on medical evaluation including medical history, physical examination, concomitant medication, vital signs, 12-lead ECG, C-SSRS responses, and clinical laboratory evaluations.
- Willingness to comply with requirements or the trial, including contraception requirements.
- Able to give fully informed consent.
Key exclusion criteria (3 listed)
- Positive tests for hepatitis B \& C, HIV. Clinically relevant history of abnormal physical or mental health. Clinically relevant abnormal laboratory results (including hepatic and renal panels, complete blood count, chemistry or coagulation panel and urinalysis), 12-lead ECG and vital signs, or physical findings.
- History of severe adverse reactions or allergies, or history of an anaphylactic reaction to prescription or non-prescription medication or food.
- Drug or alcohol abuse. Smoking. Use of medication that inhibits CYP2D6. Participation in other clinical trials of unlicensed medicines in the previous 3 months. Loss of more than 400 mL blood in the previous 3 months. Vital signs, QTcF interval or laboratory values outside the acceptable range. Predicted poor and intermediate CYP2D6 metabolisers. Clinically relevant abnormal findings at the screening assessment. History of epilepsy or seizures. Clinically relevant abnormal medical history or concurrent medical condition disease associated with cognitive impairment and/or psychosis. History of suicidal thoughts or ideation, or any history of insomnia. Use of tobacco and/or nicotine containing products within 90 days of dosing. Habitual and heavy consumption of caffeinated beverages. Consumption of cranberry, pomegranate, star fruit, grapefruit, pomelos, exotic citrus fruits or Seville oranges (including marmalade and juices made from these fruits) within 3 days before admission. Objection by General Practitioner
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 |
|---|---|---|
| HTL0016878Oral solution | Drug | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Concentration of HTL0016878 in CSF
Time frame: 2 hours
Pharmacokinetics
Concentration of HTL0016878 in CSF
Time frame: 6 hours
Pharmacokinetics
Concentration of HTL0016878 in plasma Cmax
Time frame: 0-24 hours
Pharmacokinetics
Concentration of HTL0016878 in plasma AUC
Time frame: 0-24 hours
Pharmacokinetics
1 secondary outcome
Treatment Emergent Adverse events
Time frame: Baseline up to 10 days post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HTL0016878 in people with Healthy Subjects, run by Nxera Pharma UK Limited 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 19 Apr 2021. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Concentration of HTL0016878 in CSF (time frame: 2 hours). The study lists 4 primary outcomes in all. 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 19 Apr 2021.