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ACH-0145228:in

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: Jan 14, 2021

Target and mechanism

ModalitySmall molecule

Also known as ACH-0145228: Powder-in-capsule, ACH-0145228

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment38

FDA Designations

No designations recorded

Clinical trial landscape

ACH-0145228:in · 1 trial · 1 indication

Phase 1 1
NCT04709081A Drug Interaction Study of ACH-0145228Healthy
COMPLETED38 Analytics
PHASE1COMPLETED
A Drug Interaction Study of ACH-0145228
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Part 1: Area Under The Concentration Versus Time Curve From Time 0 Extrapolated To Infinity (AUC0-inf) Of Single-dose Midazolam Under Multiple Doses Of ACH-0145228
Up to 24 hours postdose
Part 1: Maximum Observed Concentration (Cmax) Of Single-dose Midazolam Under Multiple Doses Of ACH-0145228
Up to 24 hours postdose
Part 1: Time To Maximum Observed Concentration (Tmax) Of Single-dose Midazolam Under Multiple Doses Of ACH-0145228
Up to 24 hours postdose
Part 1: AUC0-inf Of Single-dose Digoxin Under Multiple Doses Of ACH-0145228
Up to 168 hours postdose
Part 1: Cmax Of Single-dose Digoxin Under Multiple Doses Of ACH-0145228
Up to 168 hours postdose
Part 1: Tmax Of Single-dose Digoxin Under Multiple Doses Of ACH-0145228
Up to 168 hours postdose
Part 2: AUC0-inf Of Single-dose ACH-0145228 Under Multiple Doses Of Itraconazole
Up to 96 hours postdose
Part 2: Cmax Of Single-dose ACH-0145228 Under Multiple Doses Of Itraconazole
Up to 96 hours postdose
Part 2: Tmax Of Single-dose ACH-0145228 Under Multiple Doses Of Itraconazole
Up to 96 hours postdose

Secondary Endpoints

Part 1: Number Of Participants With Treatment-emergent Adverse Events (TEAEs) After Multiple Doses Of ACH-0145228 Coadministered With A Single Dose Of Midazolam
Day 1 (postdose) through follow-up (14 [+/- 2] days after last study drug administration)
Part 1: Number Of Participants With TEAEs After Multiple Doses Of ACH-0145228 Coadministered With A Single Dose Of Digoxin
Day 1 (postdose) through follow-up (14 [+/- 2] days after last study drug administration)
Part 2: Number Of Participants With TEAEs After A Single Dose Of ACH-0145228 Coadministered With Multiple Doses Of Itraconazole
Day 1 (postdose) through follow-up (14 [+/- 2] days after last study drug administration)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Part 1: ACH-0145228, Midazolam, and DigoxinEXPERIMENTALPeriod 1: Participants received single doses of midazolam and digoxin. Period 2: Participants received ACH-0145228 twice daily, in addition to coadministration with single doses of midazolam and digoxin. Scheduled pharmacokinetics (PK) blood and urine samples were collected, with a washout period of at least 7 days between collection of the last PK blood sample in Period 1 and the first dose of ACH-0145228 in Period 2.
Part 2: ACH-0145228 and ItraconazoleEXPERIMENTALPeriod 1: Participants received a single dose of ACH-0145228. Period 2: Participants received itraconazole once daily, in addition to coadministration with a single dose of ACH-0145228. Scheduled PK blood samples were collected, with a washout period of at least 2 days between collection of the last PK blood sample in Period 1 and the first dose of itraconazole in Period 2.

Interventions

NameTypeDescription
ACH-0145228DRUGACH-0145228 was dosed as 2 x 60 milligram (mg) (Part 1) or 1 x 40 mg (Part 2) powder in capsules.
MidazolamDRUGMidazolam was dosed at 2 mg (1 milliliter \[mL\] of a 2 mg/mL syrup).
DigoxinDRUGDigoxin was dosed as Lanoxin (or generic equivalent) at 1 x 0.25 mg tablet.
ItraconazoleDRUGItraconazole was dosed as Sporanox (or generic equivalent) at 200 mg (20 mL of a 10 mg/mL oral solution).
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Body mass index in the range of 18.0 to 32.0 kilograms (kg)/meter squared, inclusive, with a minimum body weight of 50.0 kg at screening. 2. No clinically significant history or presence of electrocardiogram abnormalities at screening and prior to first dosing in Period 1. 3....

Countries:United States
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Frequently asked questions about ACH-0145228:in

What is ACH-0145228?

ACH-0145228 is an investigational small molecule developed by AstraZeneca PLC. It has been studied in a Phase 1 drug interaction trial in healthy adult volunteers in the United States. It is not approved and remains in clinical development.

Who makes ACH-0145228?

ACH-0145228 is developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca sponsored the Phase 1 drug interaction study of the compound conducted in the United States.

What phase is ACH-0145228 in?

ACH-0145228 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The compound is investigational and has not been approved for any use.

What clinical trial has studied ACH-0145228?

ACH-0145228 has been evaluated in one Phase 1 study, NCT04709081, titled A Drug Interaction Study of ACH-0145228. The trial enrolled 38 healthy adult volunteers in the United States, used a controlled design, and has been completed.

Is ACH-0145228 the same as ACH-0145228: Powder-in-capsule?

Yes. ACH-0145228: Powder-in-capsule is an alternative name for ACH-0145228, referring to the same investigational compound developed by AstraZeneca PLC. Searches for either name point to the same Phase 1 small molecule program.