Study to Evaluate Properties of Radiprodil Given in Oral Solution to Healthy Volunteers

NCT02647697 | Completed Phase 1

• 2 other identifiers: UP00272015-004376-29
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the pharmacokinetics (PK) profile of Radiprodil in suspension form in healthy adult subjects.

Conditions

Healthy Volunteers

Keywords

UCB3491; Phase 1; Pharmacokinetics; Radiprodil; Healthy volunteers

Outcome Measures

Primary Outcomes (8)

• 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.

  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)

  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

  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.

  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)

  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.

  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)

  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)

  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

  From Day 1 to Day 15

Study Arms (1)

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.

Drug: Radiprodil oral

Interventions

Radiprodil oral DRUG

* Active Substance: Radiprodil * Pharmaceutical Form: dry granules for oral suspension * Concentration: 30 mg * Route of Administration: oral use

Also known as: UCB3491

Radiprodil

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Biopharma S.P.R.L.: lead
• PRA Health Sciences: collaborator

Study Sites (1)

Up002700001

Groningen, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 30705758 DERIVED

MeSH Terms

Interventions

radiprodil

Study Officials

• UCB Cares

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2016
• First Posted: January 6, 2016
• Study Start: January 1, 2016
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 10, 2016

Record last verified: 2016-02

Locations

NL (1)