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

NCT ID: NCT02548806

Last Updated: 2016-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-04-30

Brief Summary

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.

Detailed Description

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Clonidine MBT 50µg

Each subject will receive the following treatments in random order over 3 Treatment Periods (1 treatment/period): Clonidine MBT 50µg single dose, Clonidine MBT 100μg single dose ,a single-dose of reference catapres 100μg tablets.

Group Type: EXPERIMENTAL

Clonidine MBT 50µg

Intervention Type: DRUG

Clonidine MBT 50µg, single dose

Clonidine MBT 100µg

Each subject will receive the following treatments in random order over 3 Treatment Periods (1 treatment/period): Clonidine MBT 50μg single dose, Clonidine MBT 100µg single dose ,a single-dose of reference catapres 100μg tablets..

Group Type: EXPERIMENTAL

Clonidine MBT 100µg

Intervention Type: DRUG

Clonidine MBT 100µg, single dose

Catapres 100μg

Each subject will receive the following treatments in random order over 3 Treatment Periods (1 treatment/period): Clonidine MBT 50μg single dose, Clonidine MBT 100μg single dose ,a single-dose of reference catapres 100μg tablets.

Group Type: ACTIVE_COMPARATOR

Catapres 100μg

Intervention Type: DRUG

Catapres tablet 100μg, single dose

Interventions

Clonidine MBT 50µg

Clonidine MBT 50µg, single dose

Intervention Type: DRUG

Clonidine MBT 100µg

Clonidine MBT 100µg, single dose

Intervention Type: DRUG

Catapres 100μg

Catapres tablet 100μg, single dose

Intervention Type: DRUG

Other Intervention Names

Clonidine Lauriad; Clonidine Lauriad; Catapres

Eligibility Criteria

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

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Simbec Research

INDUSTRY

Sponsor Role: collaborator

Valerio Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Girish Sharma, MD

Role: PRINCIPAL_INVESTIGATOR

Simbec Research

Locations

Simbec Research Limited

Merthyr Tydfil, , United Kingdom

Countries

United Kingdom

References

Vasseur B, Dufour A, Houdas L, Goodwin H, Harries K, Emul NY, Hutchings S. Comparison of the Systemic and Local Pharmacokinetics of Clonidine Mucoadhesive Buccal Tablets with Reference Clonidine Oral Tablets in Healthy Volunteers: An Open-Label Randomised Cross-Over Trial. Adv Ther. 2017 Aug;34(8):2022-2032. doi: 10.1007/s12325-017-0585-9. Epub 2017 Jul 19.

Reference Type: DERIVED

PMID: 28726169 (View on PubMed)

Other Identifiers

OX2015/28/02

Identifier Type: -

Identifier Source: org_study_id