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Completed

NCT Number: NCT02548806

Phase 1 PK, Bioavailability, Safety Study of Clonidine MBT w Catapres in Healthy Volunteers

The purpose of this study is to determine the pharmacokinetic dose proportionality of 50 μg and 100 μg Clonidine and comparative bioavailability of clonidine with that from the Reference drug, Catapres® 100 μg oral tablets following single dose administration in healthy subjects.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Simbec Research Limited

Merthyr Tydfil, CF48 4DR, United Kingdom

About this study

A single blind, randomised, 3-period, 3-sequence single-dose crossover study to determine the pharmacokinetic dose proportionality of Clonidine MBT 50 μg and Clonidine MBT 100 μg and comparative bioavailability of clonidine from the Reference drug, Catapres® 100 μg oral tablets following single dose administration in healthy male and female subjects.

36 subjects will be randomised for 30 to complete the study. The study will comprise of 3 Treatment Periods (1, 2 and 3) and a post study follow up (7 - 12 days after the last dose). Study drug will be administered on the morning of Day 1. Pharmacokinetic (PK) blood samples will be collected for each of three treatment periods. Safety will be evaluated at specified times throughout the study. There will be at least 7 days between dose administrations.

Who can participate

Healthy volunteers accepted: Yes

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

Main Inclusion Criteria:

  • Healthy males or females (non-pregnant/non-lactating) aged 18 - 50 years.
  • A Body Mass Index (BMI) of 18-30.
  • No clinically significant abnormal serum biochemistry, haematology and urine examination values.
  • A negative urinary drugs of abuse screen.
  • Negative HIV and Hepatitis B and C results.
  • No clinically significant abnormalities in 12-lead electrocardiogram (ECG).
  • No clinically significant abnormalities in blood pressure or pulse.
  • No allergy or sensitivity to clonidine or any of its excipients.
  • No allergy to milk or milk derivatives.
  • Subjects must provide written informed consent to participate in the study

Main Exclusion Criteria:

  • Current or past medical condition that might significantly affect the pharmacokinetic or
  • pharmacodynamic response to clonidine.
  • Participation in a New Chemical Entity clinical study within the previous 3 months or a marketed drug clinical study within the previous 30 days.
  • Pathological condition of the oral cavity that would affect administration via the buccal route.
  • Raynaud's disease or other peripheral vascular disease.
  • Receipt of regular medication within 14 days of the first dose that may have an impact on the safety and objectives of the study (at the Investigator's discretion).
  • Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
  • Symptomatic postural hypotension evident on screening
  • History or evidence of Suicidal Ideation and/or behaviour as determined by using Columbia-Suicide Severity Rating Scale (C-SSRS)

Treatment and study plan

Clonidine MBT 50µg

Drug

Clonidine MBT 50µg, single dose

Other names: Clonidine Lauriad

Clonidine MBT 100µg

Drug

Clonidine MBT 100µg, single dose

Other names: Clonidine Lauriad

Catapres 100μg

Drug

Catapres tablet 100μg, single dose

Other names: Catapres

Primary outcomes

  1. Dose proportionality of two strengths of clonidine MBT (50μg and 100 μg) as assessed by Non-compartmental pharmacokinetic analysis (Area Under the Curve)

    Time frame: 3 Months

    To evaluate dose proportionality of two strengths (50 μg and 100 μg) of Clonidine MBT, by using Area Under the Curve (AUC)

  2. Bioavailability of clonidine from Clonidine MBT 50 μg and 100 μg with that from oral clonidine hydrochloride 100 μg tablets. (Area Under the Curve)

    Time frame: 3 Months

    To compare the bioavailability of clonidine from Clonidine MBT® 50 μg and 100 μg with that from oral clonidine hydrochloride 100 μg tablets, by using Area Under the Curve (AUC)

Secondary outcomes

  1. General safety information (adverse events, (AEs), 12-lead electrocardiogram (ECG) and vital signs), during the study period.

    Time frame: 3 Months

    Number of Participants With Treatment-Related Adverse Events as Assessed by Common Toxicity Criteria for Adverse Effects (CTCAE v4.0), 12-lead electrocardiogram (ECG) and vital signs

Sponsors and collaborators

Lead sponsor

Valerio Therapeutics

Industry

Collaborators

  • Simbec Research

Registry information

Official study title

Randomised Single Dose 3 Way Crossover Single Blind Study to Evaluate the Pharmacokinetic Dose Proportionality, Compare the Bioavailability and Safety of Clonidine Mucoadhesive Buccal Tablets (MBT) With Catapres in Normal Healthy Volunteers

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Sep 14, 2015
Registry last updated
Apr 18, 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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