HealthyPhase 1NCT03244228
A Two Part Study to Assess Safety, PK, PD, and Food Effect of Oral HTL0016878
A Phase 1 study testing HTL0016878 in people with Healthy, run by Nxera Pharma UK Limited at 1 site in United Kingdom.
Trial summary
Phase 1, first in human, two-part, single centre, placebo-controlled, single and multiple ascending dose trial in healthy younger and elderly adult subjects, with an open-label, randomised, crossover arms to assess the effect of food on bioavailability. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HTL0016878
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Aug 2017to 23 Sep 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Normotensive 18-55 year old (Parts 1a, 1b and 2a only) or 65+ year old (Parts 1c and 2b) male (all parts) or female (parts 1b, 2a and 2b only) volunteers with a body mass index 18-32kg/m².
- Healthy on the basis of a clinical history, physical examination, electrocardiogram (ECG), vital signs, heart rate (part 1a only), exercise history (part 1a only), and laboratory tests of blood and urine.
- 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
- severe adverse reaction to any drug
- sensitivity to trial medication
- drug or alcohol abuse
- smoking
- use of medication that inhibits CYP2D6 within previous 21 days or other prescribed and over-the-counter medication and herbal remedies within previous 21 days before dosing (with the exception of acetaminophen, contraceptive medications and hormone replacement therapy), unless the principal investigator (PI) considers that it would not interfere with trial
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- participation in other clinical trials of unlicensed medicines in the previous 3 months, or regularly take part in more than 4 studies a year
- loss of more than 500 mL blood in the previous 3 months
- vital signs, QTcF interval or laboratory values outside the acceptable range
- poor metabolizers of CYP2D6 (apart from one optional cohort in Part 1a, which may enrol poor metabolizers only)
- clinically relevant abnormal findings at the screening assessment
- acute or chronic illness
- history of epilepsy or seizures
- clinically relevant abnormal medical history or concurrent medical condition
- disease associated with cognitive impairment and/or psychosis
- recent history of suicidal thoughts or ideation, or insomnia
- excessive use of caffeine containing beverages, exceeding 8 cups of coffee or equivalent/day and the inability to refrain from the use of caffeine containing beverages whilst on the ward
- 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; possibility that volunteer will not cooperate
- pre-menopausal females who are pregnant or lactating, or who are sexually active and not using a reliable method of contraception
- Objection by the GP.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hammersmith Medicines Research
London, Hammersmith, NW10 7EW
About this study
Official title: A Two-part, Randomised, Double-blind, Placebo-controlled Single and Multiple Ascending Dose Study to Assess Safety, Pharmacokinetics and Pharmacodynamics of Oral HTL0016878 in Healthy Younger Adult and Elderly Subjects With a Randomised, Open-label, Crossover Arm to Assess the Effect of Food on Bioavailability of Oral HTL0016878.
Phase 1, first in human, two-part, single centre, placebo-controlled, single and multiple ascending dose trial in healthy younger and elderly adult subjects, with an open-label, randomised, crossover arms to assess the effect of food on bioavailability.
Read the detailed description
This is a first in human single and multiple ascending dose study with the objective to evaluate safety, tolerability, PK, PD, and food effect of HTL0016878 in healthy younger and elderly subjects. Part 1 will assess single doses of HTL0016878 and Part 2 will assess multiple doses of HTL0016878. Part 1 will be divided into 3 sub-parts: Part 1a will assess single ascending doses (SAD) of HTL0016878 in younger adult subjects, Part 1b will evaluate the effect of food on bioavailability of HTL0016878 and part 1c will investigate the effect of age on the PK of HTL0016878. Part 1c will only proceed after review of safety, tolerability and PK data from part 1a. Part 2 will be divided into 2 sub-parts to assess multiple ascending doses (MAD) of HTL0016878 in younger adult (part 2a) and elderly adult (part 2b) subjects. Part 2 will only proceed after review of safety, tolerability and PK data from Parts 1a, b and c.
- Conditions
- Healthy
- Being tested
- HTL0016878, Placebo - Concentrate
- Keywords
- First in human, Multiple ascending dose, Single ascending dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTL0016878Drug
Oral solution
Placebo - ConcentrateDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Part 1a SAD HTL0016878/Placebo | Experimental | In Part 1a, single ascending doses of HLT0016878 or matching placebo will be administered to groups of 12 subject each (9 active, 3 placebo). Each subject will have up to four treatment sessions separated by an appropriate wash-out. Healthy, young, male subjects. Receives: Drug: HTL0016878; Drug: Placebo - Concentrate |
| Part 1b single dose HTL0016878 | Experimental | In Part 1b, a single dose of HTL0016878 will be administered to 6 subjects on two occasions: once in the fasted and once the fed state. This will be open-label. Healthy, young, male or female subjects. Receives: Drug: HTL0016878 |
| Part 1c single dose HTL0016878 | Experimental | In Part 1c, a single dose of HTL0016878 will be administered to up to 6 (optional up to 12) healthy elderly subjects This will be open-label. Healthy, elderly, male subjects. Receives: Drug: HTL0016878 |
| Part 2a MAD HTL0016878/Placebo | Experimental | In Part 2a, multiple doses of HTL0016878 will be administered to up to 5 cohorts (N=8, 6 active, 2 placebo) during one study session of 7 days. Healthy, young, male or female subjects. Receives: Drug: HTL0016878; Drug: Placebo - Concentrate |
| Part 2b MAD HTL0016878/Placebo | Experimental | In Part 2b, multiple doses of HTL0016878 will be administered to up to 3 cohorts of healthy, elderly subjects (N=8, 6 active, 2 placebo) during one study session of 7 days. Healthy, young, male or female subjects. Receives: Drug: HTL0016878; Drug: Placebo - Concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment emergent adverse events (TEAEs)
Safety and Tolerability
Measured: Baseline up to 14 days post dose
Physical examinations
Safety and Tolerability
Measured: Baseline up to 14 days post dose
vital signs (Heart Rate and Blood pressure)
Safety and Tolerability
Measured: Baseline up to 14 days post dose
Laboratory safety assessment
Safety and Tolerability
Measured: Baseline up to 14 days post dose
ECG
Safety and Tolerability
Measured: Baseline up to 14 days post dose
Columbia- suicide severity rating scale (C-SSRS)
Safety and Tolerability
Measured: Baseline up to 14 days post dose
Secondary outcomes (6)
Maximum plasma concentration (Cmax) of HTL0016878
Pharmacokinetics
Measured: Baseline up to 14 days post dose
Time to Maximum plasma concentration (Tmax) of HTL0016878
Pharmacokinetics
Measured: Baseline up to 14 days post dose
Area under the curve of HTL0016878
Pharmacokinetics
Measured: Baseline up to 14 days post dose
Half-life (t1/2) of HTL0016878
Pharmacokinetics
Measured: Baseline up to 14 days post dose
Amount excreted in urine (Ae) of HTL0016878
Pharmacokinetics
Measured: Baseline up to 14 days post dose
Fraction of dose eliminated unchanged on urine (fe/F) of HTL0016878
Pharmacokinetics
Measured: Baseline up to 14 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 posted9 Aug 2017
- Study start25 Aug 2017
- Primary completion23 Sep 2019
- Study completion23 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nxera Pharma UK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Allergan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244228
- Sponsor's protocol ID
- HTL0016878-101
- Other IDs
- 2017-001385-26, 16-028, 2017
- Status last verified
- Nov 2019
- First submitted
- 3 Aug 2017
- Last updated
- 29 Nov 2019
- Results posted
- 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 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-part, Randomised, Double-blind, Placebo-controlled Single and Multiple Ascending Dose Study to Assess Safety, Pharmacokinetics and Pharmacodynamics of Oral HTL0016878 in Healthy Younger Adult and Elderly Subjects With a Randomised, Open-label, Crossover Arm to Assess the Effect of Food on Bioavailability of Oral HTL0016878.
- ClinicalTrials.gov ID
- NCT03244228
- Acronym / sponsor ID
- HTL0016878-101
- Conditions
- Healthy
- Keywords
- First in human, Multiple ascending dose, Single ascending dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Nxera Pharma UK LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Allergan
- Study start
- 25 Aug 2017 (actual)
- Primary completion
- 23 Sep 2019 (actual)
- Study completion
- 23 Sep 2019 (actual)
- First posted
- 9 Aug 2017 (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.
Phase 1, first in human, two-part, single centre, placebo-controlled, single and multiple ascending dose trial in healthy younger and elderly adult subjects, with an open-label, randomised, crossover arms to assess the effect of food on bioavailability.
Detailed description
This is a first in human single and multiple ascending dose study with the objective to evaluate safety, tolerability, PK, PD, and food effect of HTL0016878 in healthy younger and elderly subjects. Part 1 will assess single doses of HTL0016878 and Part 2 will assess multiple doses of HTL0016878. Part 1 will be divided into 3 sub-parts: Part 1a will assess single ascending doses (SAD) of HTL0016878 in younger adult subjects, Part 1b will evaluate the effect of food on bioavailability of HTL0016878 and part 1c will investigate the effect of age on the PK of HTL0016878. Part 1c will only proceed after review of safety, tolerability and PK data from part 1a. Part 2 will be divided into 2 sub-parts to assess multiple ascending doses (MAD) of HTL0016878 in younger adult (part 2a) and elderly adult (part 2b) subjects. Part 2 will only proceed after review of safety, tolerability and PK data from Parts 1a, b and c.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1a SAD HTL0016878/Placebo | Experimental | Drug: HTL0016878, Drug: Placebo - ConcentrateIn Part 1a, single ascending doses of HLT0016878 or matching placebo will be administered to groups of 12 subject each (9 active, 3 placebo). Each subject will have up to four treatment sessions separated by an appropriate wash-out. Healthy, young, male subjects. |
| Part 1b single dose HTL0016878 | Experimental | Drug: HTL0016878In Part 1b, a single dose of HTL0016878 will be administered to 6 subjects on two occasions: once in the fasted and once the fed state. This will be open-label. Healthy, young, male or female subjects. |
| Part 1c single dose HTL0016878 | Experimental | Drug: HTL0016878In Part 1c, a single dose of HTL0016878 will be administered to up to 6 (optional up to 12) healthy elderly subjects This will be open-label. Healthy, elderly, male subjects. |
| Part 2a MAD HTL0016878/Placebo | Experimental | Drug: HTL0016878, Drug: Placebo - ConcentrateIn Part 2a, multiple doses of HTL0016878 will be administered to up to 5 cohorts (N=8, 6 active, 2 placebo) during one study session of 7 days. Healthy, young, male or female subjects. |
| Part 2b MAD HTL0016878/Placebo | Experimental | Drug: HTL0016878, Drug: Placebo - ConcentrateIn Part 2b, multiple doses of HTL0016878 will be administered to up to 3 cohorts of healthy, elderly subjects (N=8, 6 active, 2 placebo) during one study session of 7 days. Healthy, young, male or female subjects. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Normotensive 18-55 year old (Parts 1a, 1b and 2a only) or 65+ year old (Parts 1c and 2b) male (all parts) or female (parts 1b, 2a and 2b only) volunteers with a body mass index 18-32kg/m².
- Healthy on the basis of a clinical history, physical examination, electrocardiogram (ECG), vital signs, heart rate (part 1a only), exercise history (part 1a only), and laboratory tests of blood and urine.
- Willingness to comply with requirements or the trial, including contraception requirements.
- Able to give fully informed consent.
Key exclusion criteria (20 listed)
- Positive tests for hepatitis B \& C, HIV
- severe adverse reaction to any drug
- sensitivity to trial medication
- drug or alcohol abuse
- smoking
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 | Part 1a SAD HTL0016878/Placebo, Part 1b single dose HTL0016878, Part 1c single dose HTL0016878, Part 2a MAD HTL0016878/Placebo, Part 2b MAD HTL0016878/Placebo |
| Placebo - ConcentrateMatching placebo | Drug | Part 1a SAD HTL0016878/Placebo, Part 2a MAD HTL0016878/Placebo, Part 2b MAD HTL0016878/Placebo |
Primary outcome
Treatment emergent adverse events (TEAEs)
Time frame: Baseline up to 14 days post dose
Safety and Tolerability
Physical examinations
Time frame: Baseline up to 14 days post dose
Safety and Tolerability
vital signs (Heart Rate and Blood pressure)
Time frame: Baseline up to 14 days post dose
Safety and Tolerability
Laboratory safety assessment
Time frame: Baseline up to 14 days post dose
Safety and Tolerability
ECG
Time frame: Baseline up to 14 days post dose
Safety and Tolerability
Columbia- suicide severity rating scale (C-SSRS)
Time frame: Baseline up to 14 days post dose
Safety and Tolerability
6 secondary outcomes
Maximum plasma concentration (Cmax) of HTL0016878
Time frame: Baseline up to 14 days post dose
Time to Maximum plasma concentration (Tmax) of HTL0016878
Time frame: Baseline up to 14 days post dose
Area under the curve of HTL0016878
Time frame: Baseline up to 14 days post dose
Half-life (t1/2) of HTL0016878
Time frame: Baseline up to 14 days post dose
Amount excreted in urine (Ae) of HTL0016878
Time frame: Baseline up to 14 days post dose
Fraction of dose eliminated unchanged on urine (fe/F) of HTL0016878
Time frame: Baseline up to 14 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 29 Nov 2019.
- 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, 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 4 inclusion and 20 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 29 Nov 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?
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?
Treatment emergent adverse events (TEAEs) (time frame: Baseline up to 14 days post dose). The study lists 6 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 29 Nov 2019; AzTrials last refreshed its copy on 30 Oct 2026.