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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02548806
• Other study ID #: OX2015/28/02
• Status: Completed
• Phase: Phase 1
• First received: September 2, 2015
• Last updated: April 15, 2016
• Start date: September 2015
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Onxeo
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Clonidine MBT 50µg
Clonidine MBT 50µg, single dose
• Clonidine MBT 100µg
Clonidine MBT 100µg, single dose
• Catapres 100µg
Catapres tablet 100µg, single dose

Locations

Country	Name	City	State
United Kingdom	Simbec Research Limited	Merthyr Tydfil

Sponsors (2)

Lead Sponsor	Collaborator
Onxeo	Simbec Research

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose proportionality of two strengths of clonidine MBT (50µg and 100 µg) as assessed by Non-compartmental pharmacokinetic analysis (Area Under the Curve)	To evaluate dose proportionality of two strengths (50 µg and 100 µg) of Clonidine MBT, by using Area Under the Curve (AUC)	3 Months	No
Primary	Bioavailability of clonidine from Clonidine MBT 50 µg and 100 µg with that from oral clonidine hydrochloride 100 µg tablets. (Area Under the Curve)	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)	3 Months	No
Secondary	General safety information (adverse events, (AEs), 12-lead electrocardiogram (ECG) and vital signs), during the study period.	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	3 Months	Yes