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Completed

NCT Number: NCT02647697

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

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

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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Up002700001

Groningen, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Radiprodil oral

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

Other names: UCB3491

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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.

  5. 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

  6. 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.

  7. 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

  8. 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

Secondary outcomes

  1. Number of subjects reporting at least one treatment-emergent Adverse Event (AE) during the study

    Time frame: From Day 1 to Day 15

    Treatment-emergent adverse event is an adverse event starting after the first study drug administration.

Sponsors and collaborators

Lead sponsor

UCB Biopharma S.P.R.L.

Industry

Collaborators

  • PRA Health Sciences

Registry information

Official study title

A Single Oral Dose Study of the Safety, Tolerability, and Pharmacokinetic Profile of Radiprodil in Adult Healthy Volunteers

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 6, 2016
Registry last updated
Feb 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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