Healthy VolunteersPhase 1NCT02647697
Study to Evaluate Properties of Radiprodil Given in Oral Solution to Healthy Volunteers
A Phase 1 study testing Radiprodil oral in people with Healthy Volunteers, run by UCB Biopharma S.P.R.L. at 1 site in Netherlands.
Trial summary
To evaluate the pharmacokinetics (PK) profile of Radiprodil in suspension form in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Radiprodil oral
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2016to Feb 2016
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is male or female, ≥ 18 years to ≤ 45 years of age
- Subject smokes < 10 cigarettes per day and has a score of < 4 on the Fagerström Test for Nicotine Dependence (Heatherthon et al., 1991). The Fagerström Test is not required for nonsmokers (ie, no smoking for at least 6 months)
- Subject has a body mass index (BMI) of 18 to 30 kg/m² (inclusive), with a body weight of at least 50 kg (male) or 45 kg (female)
- Subject has a blood pressure and pulse rate within the normal range in supine position after 5 minutes rest (systolic blood pressure: 90 mmHg to 140 mm Hg, diastolic blood pressure: 45 mmHg to 90 mmHg, pulse rate: 45 bpm to 90 bpm)
Who cannot join
- Subject has a known hypersensitivity to any components of Radiprodil liquid formulation including the excipients or a history of drug or other allergy that, in the opinion of the Investigator or UCB Study Physician, contraindicates his/her participation
- Subject has received prescription or nonprescription medicines (including over-the-counter medicines and herbal and dietary supplements [including St John's Wort]) within 14 days. Exceptions:
- Paracetamol for the treatment of mild symptoms (eg, headache or other pain), given at most every 6 h to 8 h, not exceeding 2 g/day, and with a total of no more than 5 g over 7 days
- Inhaled corticosteroids for seasonal rhinitis
- Vitamins within recommended daily dose Limits
- Subject has consumed any grapefruit, grapefruit juice, grapefruit-containing products, or star fruit within 14 days prior to administration of Radiprodil
- Subject has a history of unexplained syncope or a family history of sudden death due to long QT syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Oral Dose Study of the Safety, Tolerability, and Pharmacokinetic Profile of Radiprodil in Adult Healthy Volunteers
To evaluate the pharmacokinetics (PK) profile of Radiprodil in suspension form in healthy adult subjects.
Read the detailed description
UP0027 is a Phase 1, single-center, open-label study to investigate the safety, tolerability, and PK profile of radiprodil in healthy adult male and female subjects after a single fasting oral dose of radiprodil 30 mg suspension formulation. A total of 10 subjects will be enrolled in the study.
The primary objective of the study is to evaluate the PK profile of oral radiprodil in suspension form in healthy adult subjects.
The secondary objective of the study is to evaluate the safety and tolerability of oral radiprodil in suspension form in healthy adult subjects.
The exploratory objectives of the study are to evaluate the comparative PK profile of radiprodil from samples collected using 2 alternative microsampling techniques (MITRA™ and Drummond capillary tubes) with that of conventional venous blood samples, and to test the perception of the taste and texture of the oral radiprodil suspension.
- Conditions
- Healthy Volunteers
- Being tested
- Radiprodil oral
- Keywords
- UCB3491, Phase 1, Pharmacokinetics, Radiprodil, Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiprodil oralDrug
Also called UCB3491
- Active Substance: Radiprodil
- Pharmaceutical Form: dry granules for oral suspension
- Concentration: 30 mg
- Route of Administration: oral use
| Study group | Role | What they receive |
|---|---|---|
| Radiprodil | Experimental | Subjects will receive a single dose of Radiprodil 30 mg in suspension form, orally via a syringe in the morning of Day 1. Receives: Drug: Radiprodil oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area under the concentration-time curve of Radiprodil from dosing to time t (AUC(0-t))
The area under the concentration-time curve of Radiprodil from dosing to time t (AUC(0-t)) is computed from plasma concentrations of pharmacokinetic samples taken predose and 0.5h, 1h, 1.5h, 2 h, 2.5h, 3 h, 3.5h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, and 48 h post dose using non-compartmental analysis.
Measured: Blood samples will be taken pre-dose on Day 1 and 0.5 h, 1 h, Pre-dose, 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 3.5 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, and 48 h post dose
The apparent terminal elimination half-life of Radiprodil (t1/2)
Measured: Blood samples will be taken pre-dose on Day 1 and 0.5 h, 1 h, Pre-dose, 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 3.5 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, and 48 h post dose
The maximum observed plasma concentration of Radiprodil (Cmax)
The Cmax is the maximum plasma concentration of radiprodil observed from pharmacokinetic samples taken predose and 0.5h, 1h, 1.5h, 2 h, 2.5h, 3 h, 3.5h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, and 48 h post dose
Measured: Blood samples will be taken pre-dose on Day 1 and 0.5 h, 1 h, Pre-dose, 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 3.5 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, and 48 h post dose
The time of occurrence of Cmax of Radiprodil (Tmax)
Time to reach maximum plasma concentration.
Measured: Blood samples will be taken pre-dose on Day 1 and 0.5 h, 1 h, Pre-dose, 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 3.5 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, and 48 h post dose
The volume of distribution of Radiprodil (Vd)
Measured: Blood samples will be taken pre-dose on Day 1 and 0.5 h, 1 h, Pre-dose, 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 3.5 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, and 48 h post dose
The area under the concentration-time curve from dosing extrapolated to infinity of Radiprodil (AUC)
The area under the concentration-time curve of Radiprodil from dosing extrapolated to infinity (AUC) is computed from plasma concentrations of pharmacokinetic samples taken predose and 0.5h, 1h, 1.5h, 2 h, 2.5h, 3 h, 3.5h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, and 48 h post dose dose using non-compartmental analysis.
Measured: Blood samples will be taken pre-dose on Day 1 and 0.5 h, 1 h, Pre-dose, 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 3.5 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, and 48 h post dose
The individual estimate of the terminal elimination rate constant of Radiprodil (λz)
Measured: Blood samples will be taken pre-dose on Day 1 and 0.5 h, 1 h, Pre-dose, 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 3.5 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, and 48 h post dose
The apparent total body clearance of Radiprodil (CL/F)
Measured: Blood samples will be taken pre-dose on Day 1 and 0.5 h, 1 h, Pre-dose, 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 3.5 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, and 48 h post dose
Secondary outcomes (1)
Number of subjects reporting at least one treatment-emergent Adverse Event (AE) during the study
Treatment-emergent adverse event is an adverse event starting after the first study drug administration.
Measured: From Day 1 to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma S.P.R.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647697
- Sponsor's protocol ID
- UP0027
- Other IDs
- 2015-004376-29, 2015
- Status last verified
- Feb 2016
- First submitted
- 4 Jan 2016
- Last updated
- 10 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Sciberras D, Otoul C, Lurquin F, Smeraglia J, Lappert A, De Bruyn S, Jaap van Lier J. A pharmacokinetic study of radiprodil oral suspension in healthy adults comparing conventional venous blood sampling with two microsampling techniques. Pharmacol Res Perspect. 2019 Jan 28;7(1):e00459. doi: 10.1002/prp2.459. eCollection 2019 Feb.
PubMed 30705758
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Oral Dose Study of the Safety, Tolerability, and Pharmacokinetic Profile of Radiprodil in Adult Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02647697
- Acronym / sponsor ID
- UP0027
- Conditions
- Healthy Volunteers
- Keywords
- UCB3491, Phase 1, Pharmacokinetics, Radiprodil, Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- UCB Biopharma S.P.R.L.Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Study start
- Jan 2016
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 6 Jan 2016 (estimated)
- 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.
To evaluate the pharmacokinetics (PK) profile of Radiprodil in suspension form in healthy adult subjects.
Detailed description
UP0027 is a Phase 1, single-center, open-label study to investigate the safety, tolerability, and PK profile of radiprodil in healthy adult male and female subjects after a single fasting oral dose of radiprodil 30 mg suspension formulation. A total of 10 subjects will be enrolled in the study.
The primary objective of the study is to evaluate the PK profile of oral radiprodil in suspension form in healthy adult subjects.
The secondary objective of the study is to evaluate the safety and tolerability of oral radiprodil in suspension form in healthy adult subjects.
The exploratory objectives of the study are to evaluate the comparative PK profile of radiprodil from samples collected using 2 alternative microsampling techniques (MITRA™ and Drummond capillary tubes) with that of conventional venous blood samples, and to test the perception of the taste and texture of the oral radiprodil suspension.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiprodil | Experimental | Drug: Radiprodil oralSubjects will receive a single dose of Radiprodil 30 mg in suspension form, orally via a syringe in the morning of Day 1. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subject is male or female, ≥ 18 years to ≤ 45 years of age
- Subject smokes < 10 cigarettes per day and has a score of < 4 on the Fagerström Test for Nicotine Dependence (Heatherthon et al., 1991). The Fagerström Test is not required for nonsmokers (ie, no smoking for at least 6 months)
- Subject has a body mass index (BMI) of 18 to 30 kg/m² (inclusive), with a body weight of at least 50 kg (male) or 45 kg (female)
- Subject has a blood pressure and pulse rate within the normal range in supine position after 5 minutes rest (systolic blood pressure: 90 mmHg to 140 mm Hg, diastolic blood pressure: 45 mmHg to 90 mmHg, pulse rate: 45 bpm to 90 bpm)
Key exclusion criteria (7 listed)
- Subject has a known hypersensitivity to any components of Radiprodil liquid formulation including the excipients or a history of drug or other allergy that, in the opinion of the Investigator or UCB Study Physician, contraindicates his/her participation
- Subject has received prescription or nonprescription medicines (including over-the-counter medicines and herbal and dietary supplements [including St John's Wort]) within 14 days. Exceptions:
- Subject has consumed any grapefruit, grapefruit juice, grapefruit-containing products, or star fruit within 14 days prior to administration of Radiprodil
- Subject has a history of unexplained syncope or a family history of sudden death due to long QT syndrome
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 |
|---|---|---|
| Radiprodil oralAlso: UCB3491* Active Substance: Radiprodil * Pharmaceutical Form: dry granules for oral suspension * Concentration: 30 mg * Route of Administration: oral use | Drug | Radiprodil |
Primary outcome
The area under the concentration-time curve of Radiprodil from dosing to time t (AUC(0-t))
Time frame: Blood samples will be taken pre-dose on Day 1 and 0.5 h, 1 h, Pre-dose, 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 3.5 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, and 48 h post dose
The area under the concentration-time curve of Radiprodil from dosing to time t (AUC(0-t)) is computed from plasma concentrations of pharmacokinetic samples taken predose and 0.5h, 1h, 1.5h, 2 h, 2.5h, 3 h, 3.5h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, and 48 h post dose using non-compartmental analysis.
The apparent terminal elimination half-life of Radiprodil (t1/2)
Time frame: Blood samples will be taken pre-dose on Day 1 and 0.5 h, 1 h, Pre-dose, 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 3.5 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, and 48 h post dose
The maximum observed plasma concentration of Radiprodil (Cmax)
Time frame: Blood samples will be taken pre-dose on Day 1 and 0.5 h, 1 h, Pre-dose, 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 3.5 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, and 48 h post dose
The Cmax is the maximum plasma concentration of radiprodil observed from pharmacokinetic samples taken predose and 0.5h, 1h, 1.5h, 2 h, 2.5h, 3 h, 3.5h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, and 48 h post dose
The time of occurrence of Cmax of Radiprodil (Tmax)
Time frame: Blood samples will be taken pre-dose on Day 1 and 0.5 h, 1 h, Pre-dose, 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 3.5 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, and 48 h post dose
Time to reach maximum plasma concentration.
The volume of distribution of Radiprodil (Vd)
Time frame: Blood samples will be taken pre-dose on Day 1 and 0.5 h, 1 h, Pre-dose, 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 3.5 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, and 48 h post dose
The area under the concentration-time curve from dosing extrapolated to infinity of Radiprodil (AUC)
Time frame: Blood samples will be taken pre-dose on Day 1 and 0.5 h, 1 h, Pre-dose, 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 3.5 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, and 48 h post dose
The area under the concentration-time curve of Radiprodil from dosing extrapolated to infinity (AUC) is computed from plasma concentrations of pharmacokinetic samples taken predose and 0.5h, 1h, 1.5h, 2 h, 2.5h, 3 h, 3.5h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, and 48 h post dose dose using non-compartmental analysis.
The individual estimate of the terminal elimination rate constant of Radiprodil (λz)
Time frame: Blood samples will be taken pre-dose on Day 1 and 0.5 h, 1 h, Pre-dose, 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 3.5 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, and 48 h post dose
The apparent total body clearance of Radiprodil (CL/F)
Time frame: Blood samples will be taken pre-dose on Day 1 and 0.5 h, 1 h, Pre-dose, 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 3.5 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, and 48 h post dose
1 secondary outcome
Number of subjects reporting at least one treatment-emergent Adverse Event (AE) during the study
Time frame: From Day 1 to Day 15
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 10 Feb 2016.
- Derived from this study: PubMed 30705758Sciberras D, Otoul C, Lurquin F, Smeraglia J, Lappert A, De Bruyn S, Jaap van Lier J. A pharmacokinetic study of radiprodil oral suspension in healthy adults comparing conventional venous blood sampling with two microsampling techniques. Pharmacol Res Perspect. 2019 Jan 28;7(1):e00459. doi: 10.1002/prp2.459. eCollection 2019 Feb.
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Healthy Participants
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.
UCB Cares study director
+1 877 822 9493 (UCB)
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 Radiprodil oral in people with Healthy Volunteers, run by UCB Biopharma S.P.R.L. at 1 site in Netherlands.
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 7 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 10 Feb 2016. 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 Netherlands. 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?
The area under the concentration-time curve of Radiprodil from dosing to time t (AUC(0-t)) (time frame: Blood samples will be taken pre-dose on Day 1 and 0.5 h, 1 h, Pre-dose, 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 3.5 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, and 48 h post dose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02647697, which also lists 1 linked publication.
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 10 Feb 2016.