Study to Investigate the Safety, Tolerability, and Pharmacokinetic Profile With Oral AB521 in Healthy Volunteers

NCT ID: NCT05117554

Last Updated: 2024-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-09
• Study Completion Date: 2023-02-17

Brief Summary

This study will evaluate the safety and tolerability, pharmacokinetic, and pharmacodynamic profile, and drug-drug interaction (DDI) of casdatifan in healthy participants.

Conditions

Healthy Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SAD-casdatifan Dose 1

Participants will receive "Dose 1" of casdatifan orally with water under fasting conditions.

Group Type: EXPERIMENTAL

casdatifan

Intervention Type: DRUG

Capsule

SAD-casdatifan Dose 2

Participants will receive "Dose 2" of casdatifan orally with water under fasting conditions.

Group Type: EXPERIMENTAL

casdatifan

Intervention Type: DRUG

Capsule

SAD-casdatifan Dose 3

Participants will receive "Dose 3" of casdatifan orally with water under fasting conditions.

Group Type: EXPERIMENTAL

casdatifan

Intervention Type: DRUG

Capsule

SAD-casdatifan Dose 4

Participants will receive "Dose 4" of casdatifan orally with water under fasting conditions.

Group Type: EXPERIMENTAL

casdatifan

Intervention Type: DRUG

Capsule

SAD-Placebo

Participants will receive matching placebo orally with water under fasting conditions.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Capsule

MAD-casdatifan Dose 1

Participants will receive "Dose 1" of casdatifan orally with water under fasting conditions.

Group Type: EXPERIMENTAL

casdatifan

Intervention Type: DRUG

Capsule

MAD-casdatifan Dose 2

Participants will receive "Dose 2" of casdatifan orally with water under fasting conditions.

Group Type: EXPERIMENTAL

casdatifan

Intervention Type: DRUG

Capsule

MAD-Placebo

Participants will receive matching placebo orally with water under fasting conditions.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Capsule

DDI-casdatifan Dose + Midazolam

Participants will receive highest safe dose level of casdatifan from MAD and midazolam orally with water under fasting conditions

Group Type: EXPERIMENTAL

casdatifan

Intervention Type: DRUG

Capsule

Midazolam

Intervention Type: DRUG

Syrup solution

Interventions

casdatifan

Capsule

Intervention Type: DRUG

Placebo

Capsule

Intervention Type: DRUG

Midazolam

Syrup solution

Intervention Type: DRUG

Other Intervention Names

AB521

Eligibility Criteria

Inclusion Criteria

• Participants who are healthy volunteers (in the opinion of the investigator) as determined by pre-study medical history, physical examination, vital signs, and 12-lead electrocardiogram (ECG)
• All clinical laboratory tests of blood and urine must be within the normal range or show no clinically relevant excursions from the normal range as judged by Principal Investigator at screening and admission.
• Screening and randomization hemoglobin ≥for males and females is as follows:

• SAD: male and female hemoglobin level ≥ 12.5 grams/ deciliters (g/dL) (7.7 millimoles/liters [mmol/L])
• MAD and DDI: male hemoglobin level ≥ 14.2 g/dL (8.8 mmol/L) and female hemoglobin level ≥ 12.5 g/dL (7.7 mmol/L).
• Participants should have adequate peripheral venous access.
• Body weight of 45 kilograms (kg) or greater and body mass index within the range of 18 to 32 kg/meters squared (m^2) (inclusive)
• Male participants must be vasectomized and have been vasectomized for at least 3 months prior to screening visit with confirmed history of azoospermia subsequent to the vasectomy procedure
• Contraceptive use should be consistent with local regulations

Exclusion Criteria

• Has any (acute or chronic [including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection]) medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study
• Has history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, cerebrovascular, neurological, or other major disorders capable of significantly altering the absorption, metabolism, or elimination of investigational drug; constituting a risk when taking the study intervention; or interfering with the interpretation of data in the opinion of the investigator
• Abnormal blood pressure (BP) or pulse measurements at the Screening Visit or Day -2/-1 (Admission) in a supine position after 5 minutes of rest as follows: mean systolic BP ≥139 millimeters of mercury (mm Hg) or mean diastolic BP ≥89 mm Hg; mean pulse < 40 beats per minute (bpm) or > 100 bpm.
• Liver enzyme test results: Alanine aminotransferase, aspartate aminotransferase, bilirubin, or alkaline phosphatase >1.0x the upper limit of normal
• Current or chronic history of liver disease or known hepatic or biliary abnormalities
• Has 12-lead electrocardiogram with changes considered to be clinically significant at the Screening Visit or day of admission

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Arcus Biosciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Arcus Biosciences, Inc.

Locations

Investigational Site

Groningen, , Netherlands

Countries

Netherlands

Related Links

https://trials.arcusbio.com/study/?id=ARC-14

ARC-14 - Public website

Other Identifiers

2021-003856-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ARC-14

Identifier Type: -

Identifier Source: org_study_id