Single Ascending Dose Study to Evaluate Pharmacokinetics and Food-Effect in Healthy Volunteers

Asana BioSciences

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: ASN002

Study type: Interventional

Funder types: Industry

Identifiers

NCT02853643

ASN002-102

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and tolerability, and determine the blood levels (pharmacokinetics), in both a fed and fasted condition, of a single dose of ASN002. Healthy volunteers will be participants in the study.

Enrollment: 22 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male or female, non-smoking subjects.
2. Willing to use contraception throughout the duration of the study and for 90 days after the study.
3. Capable of consent.

Exclusion criteria

Subjects to whom any of the following applies will be excluded from the study:

1. Any clinically significant abnormality, infection, exposure to infection, recent live virus vaccination, or abnormal laboratory test results found during medical screening.
2. History of alcohol or drug abuse, or a positive urine drug screen or breath alcohol test at screening.
3. History of allergic reactions to protein kinase inhibitors, or significant allergic reactions to any drug.
4. Positive pregnancy test at screening.
5. Clinically significant ECG abnormalities.
6. Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration.
7. Use of medication other than topical products without significant systemic absorption:
8. Donation of plasma within 7 days prior to dosing, or significant blood loss within the past 56 days.
9. Subject is pregnant, or breast feeding.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 3 patient groups

25 mg Dose

Experimental group

Description:

Single dose of 25 mg ASN002

Treatment:

Drug: ASN002

50 mg Dose

Experimental group

Description:

Single dose of 50 mg ASN002

Treatment:

Drug: ASN002

100 mg Food effect cross over

Experimental group

Description:

100 mg single dose under both fasted and fed conditions in a cross over fashion

Treatment:

Drug: ASN002