Study in Healthy Volunteers to Investigate the Effects of Ketoconazole on the Pharmacokinetics of NKTR-118

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers; Drug- Drug Interactions; Bioavailability

Treatments: Drug: Ketoconazole; Drug: NKTR-118

Study type: Interventional

Funder types: Industry

Identifiers

NCT01520896

D3820C00012

Details and patient eligibility

About

Study in healthy volunteers to investigate the effects of Ketoconazole on the Pharmacokinetics of NKTR-118

Full description

An Open-label, 1-sequence, 3-period, 3-treatment, Crossover Study to Assess the Effects of Ketoconazole on the Pharmacokinetics of NKTR-118 in Healthy Subjects

Enrollment: 22 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision of signed and dated, written informed consent prior to any study specific procedures.
• Male and female (nonchildbearing potential, nonlactating)healthy volunteers aged 18 to 55 years inclusive, with suitable veins for cannulation or repeated venipuncture.
• Female volunteers must have a negative pregnancy test at screening and at admission, must not be lactating, and must be of nonchildbearing potential.
• Male volunteers should be willing to use barrier contraception ie, condoms, from the first day of dosing until 3 months after dosing with the IP. The female partner should use contraception during this period.
• Volunteers must have a BMI between 18 and 30 kg/m2, inclusive, and weigh at least 50 kg.

Exclusion criteria

• Any clinically significant disease or disorder (eg, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, or major physical impairment), as judged by the Investigator.
• Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IP.
• Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results as judged by the Investigator.
• Significant orthostatic reaction at enrollment as judged by the Investigator.
• Abnormal vital signs, after 10 minutes supine rest as defined in protocol.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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22 participants in 3 patient groups

Part 1 - A

Experimental group

Description:

Single dose NKTR-118 25 mg on Day 1 only

Treatment:

Drug: NKTR-118

Part 1 - B

Active Comparator group

Description:

Ketoconazole 400 mg once daily on Days 4 to 8

Treatment:

Drug: Ketoconazole

Part 1- C

Active Comparator group

Description:

Ketoconazole 400 mg plus NKTR-118 25 mg on Day 7

Treatment:

Drug: NKTR-118

Drug: Ketoconazole