Clinical trial NCT02446171
Conditions: Bioavailability Healthy Subjects
Keywords: naloxegol tablet crushed naloxegol oral solution naloxegol whole tablet relative bioavailability Phase I healthy subjects
Sponsor: AstraZeneca
Start date: 2015-05-01; Completion date: 2015-07-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This clinical study is an open-label, randomized, 4-period, 4-treatment, crossover, single-center, single-dose bioavailability study with alternate methods of administration of crushed naloxegol tablets, 25 mg and of a naloxegol solution formulation, 25 mg, compared to whole naloxegol tablets, 25 mg, in healthy subjects.

The main objective of this study is to determine the bioavailability of each of three alternative methods of naloxegol administration compared to whole naloxegol tablets given orally by assessment of the primary pharmacokinetic (PK) parameters of naloxegol

Detailed description:
This is an open-label, randomized, 4-period, 4-treatment, crossover, single-center, single-dose bioavailability study with alternate methods of administration of naloxegol: crushed and suspended in water and administered orally (Treatment A),crushed and suspended in water administered via nasogastric tube (Treatment B), solution administered orally (Treatment C) and tablet swallowed as a whole (Treatment D).

Alternative ways of administering a tablet may be useful to help patients who, for different reasons, have difficulties with swallowing a whole tablet. Administration of dispersed (crushed) tablets suspended in water is a common way of administering drugs to these patients. A useful method in patients whose condition prevents swallowing is administration of dispersed tablets through nasogastric tubes. Additionally a solution formulation may be an attractive option for some patients including the pediatric population. The main aim in this clinical study is to investigate whether the blood concentrations of naloxegol (pharmacokinetic) after each treatment A, B and C is comparable to that after treatment D. Additionally, the safety and tolerability shall be assessed.

Arms: arm 1: Treatment A in Period 1, Treatment D in Period 2, Treatment B in Period 3 and Treatment C in Period 4 arm 2: Treatment B in Period 1, Treatment A in Period 2, Treatment C in Period 3 and Treatment D in Period 4 arm 3: Treatment C in Period 1, Treatment B in Period 2, Treatment D in Period 3 and Treatment A in Period 4 arm 4: Treatment D in Period 1, Treatment C in Period 2, Treatment A in Period 3 and Treatment B in Period 4
Interventions: intervention 1: Naloxegol 25 mg tablet, crushed, suspended in water, given orally intervention 2: Naloxegol 25mg tablet crushed, suspended in water, given via nasogastric tube intervention 3: Naloxegol 25 mg (10 mL oral solution) intervention 4: Naloxegol 25 mg tablet, given orally
Intervention descriptions: intervention 1: naloxegol 25 mg (1 tablet) crushed, suspended in water, given orally intervention 2: naloxegol 25 mg (1 tablet) crushed, suspended in water, given via nasogastric tube intervention 3: naloxegol 25 mg (10 mL oral solution) intervention 4: naloxegol 25 mg (1 tablet) whole tablet, given orally

Protocol documents: