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

NCT02548806 | Completed Phase 1

• 1 other identifier: OX2015/28/02
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Clonidine

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (1)

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

  3 Months

Study Arms (3)

Clonidine MBT 50µg

EXPERIMENTAL

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.

Drug: Clonidine MBT 50µg

Clonidine MBT 100µg

EXPERIMENTAL

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..

Drug: Clonidine MBT 100µg

Catapres 100μg

ACTIVE COMPARATOR

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.

Drug: Catapres 100μg

Interventions

Clonidine MBT 50µg DRUG

Clonidine MBT 50µg, single dose

Also known as: Clonidine Lauriad

Clonidine MBT 50µg

Clonidine MBT 100µg DRUG

Clonidine MBT 100µg, single dose

Also known as: Clonidine Lauriad

Clonidine MBT 100µg

Catapres 100μg DRUG

Catapres tablet 100μg, single dose

Also known as: Catapres

Catapres 100μg

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Valerio Therapeutics: lead
• Simbec Research: collaborator

Study Sites (1)

Simbec Research Limited

Merthyr Tydfil, CF48 4DR, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 28726169 DERIVED

MeSH Terms

Interventions

Clonidine

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Girish Sharma, MD

  Simbec Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2015
• First Posted: September 14, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: April 1, 2016
• Last Updated: April 18, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)