A Bioavailability Study with Alternate Methods of Administration of Naloxegol Tablets, and Solution

Study identifier:D3820C00035

ClinicalTrials.gov identifier:NCT02446171

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Bioavailability, Healthy subjects

Phase

Phase 1

Healthy volunteers

Study drug

Naloxegol 25 mg tablet, crushed, suspended in water, given orally, Naloxegol 25mg tablet crushed, suspended in water, given via nasogastric tube, Naloxegol 25 mg (10 mL oral solution), Naloxegol 25 mg tablet, given orally

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 01 May 2015

Primary Completion Date: 01 Jul 2015

Study Completion Date: 01 Jul 2015

Study design

Allocation: Randomized
Endpoint Classification: Bio-availability
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Verification:

Verified 01 Jan 2017 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- Healthy male and female subjects aged 18 to 55 years with suitable veins for cannulation or repeated venipuncture.
- Females must have a negative pregnancy test at screening and on admission to the clinical unit, must not be lactating and must be of non childbearing potential, confirmed at screening by fulfilling one of the following criteria:
• Post-menopausal defined as amenorrhea for at least 12 months or more following cessation of all exogenous hormonal treatments and follicle-stimulating hormone (FSH) levels in the post-menopausal range.
• Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy; but not tubal ligation.
- Have a body mass index (BMI) between 18.5 and 29.9 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
- Able to understand, read and speak the German language.

Exclusion Criteria

- History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the potential subject at risk because of participation in the study, or influence the results or the potential subject’s ability to participate in the study.
- Current smokers or those who have smoked or used nicotine products within the previous 3 months.
- Use of drugs with enzyme-inducing properties such as St John’s Wort within 3 weeks prior to the first administration of IMP.
Drugs include known CYP3A4 and/or P-gp inhibitors and inducers, e.g., diltiazem, verapamil, and erythromycin
- Use of any prescribed or non-prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during 2 weeks prior to the first administration of IMP or longer if the medication has a long half-life.
For females, hormonal replacement therapy is not allowed.
- Subject with a relevant history of a suicide attempt or suicidal behavior. Any recent suicidal ideation within the last 6 months (a level of 4 or 5), or who are at significant risk to commit suicide, as judged by the investigator using the Columbia-Suicide Severity Rating Scale (C-SSRS).
- Applicable to subjects willing to participate in genetic research: Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection or previous bone marrow transplant.

No locations available

Arms	Assigned Interventions
Experimental: Treatments A-D-B-C sequence Treatment A in Period 1, Treatment D in Period 2, Treatment B in Period 3 and Treatment C in Period 4	Drug: Naloxegol 25 mg tablet, crushed, suspended in water, given orally naloxegol 25 mg (1 tablet) crushed, suspended in water, given orally Other Name: Treatment A Other Name: (Test product) Drug: Naloxegol 25mg tablet crushed, suspended in water, given via nasogastric tube naloxegol 25 mg (1 tablet) crushed, suspended in water, given via nasogastric tube Other Name: Treatment B Other Name: (Test product) Drug: Naloxegol 25 mg (10 mL oral solution) naloxegol 25 mg (10 mL oral solution) Other Name: Treatment C Other Name: (Test product) Drug: Naloxegol 25 mg tablet, given orally naloxegol 25 mg (1 tablet) whole tablet, given orally Other Name: Treatment D Other Name: (Reference product)
Experimental: Treatments B-A-C-D sequence Treatment B in Period 1, Treatment A in Period 2, Treatment C in Period 3 and Treatment D in Period 4	Drug: Naloxegol 25 mg tablet, crushed, suspended in water, given orally naloxegol 25 mg (1 tablet) crushed, suspended in water, given orally Other Name: Treatment A Other Name: (Test product) Drug: Naloxegol 25mg tablet crushed, suspended in water, given via nasogastric tube naloxegol 25 mg (1 tablet) crushed, suspended in water, given via nasogastric tube Other Name: Treatment B Other Name: (Test product) Drug: Naloxegol 25 mg (10 mL oral solution) naloxegol 25 mg (10 mL oral solution) Other Name: Treatment C Other Name: (Test product) Drug: Naloxegol 25 mg tablet, given orally naloxegol 25 mg (1 tablet) whole tablet, given orally Other Name: Treatment D Other Name: (Reference product)
Experimental: Treatments C-B-D-A sequence Treatment C in Period 1, Treatment B in Period 2, Treatment D in Period 3 and Treatment A in Period 4	Drug: Naloxegol 25 mg tablet, crushed, suspended in water, given orally naloxegol 25 mg (1 tablet) crushed, suspended in water, given orally Other Name: Treatment A Other Name: (Test product) Drug: Naloxegol 25mg tablet crushed, suspended in water, given via nasogastric tube naloxegol 25 mg (1 tablet) crushed, suspended in water, given via nasogastric tube Other Name: Treatment B Other Name: (Test product) Drug: Naloxegol 25 mg (10 mL oral solution) naloxegol 25 mg (10 mL oral solution) Other Name: Treatment C Other Name: (Test product) Drug: Naloxegol 25 mg tablet, given orally naloxegol 25 mg (1 tablet) whole tablet, given orally Other Name: Treatment D Other Name: (Reference product)
Experimental: Treatments D-C-A-B sequence Treatment D in Period 1, Treatment C in Period 2, Treatment A in Period 3 and Treatment B in Period 4	Drug: Naloxegol 25 mg tablet, crushed, suspended in water, given orally naloxegol 25 mg (1 tablet) crushed, suspended in water, given orally Other Name: Treatment A Other Name: (Test product) Drug: Naloxegol 25mg tablet crushed, suspended in water, given via nasogastric tube naloxegol 25 mg (1 tablet) crushed, suspended in water, given via nasogastric tube Other Name: Treatment B Other Name: (Test product) Drug: Naloxegol 25 mg (10 mL oral solution) naloxegol 25 mg (10 mL oral solution) Other Name: Treatment C Other Name: (Test product) Drug: Naloxegol 25 mg tablet, given orally naloxegol 25 mg (1 tablet) whole tablet, given orally Other Name: Treatment D Other Name: (Reference product)

Documents available

D3820C00035_Study_Protocol_Redacted
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

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