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A Study to Examine the Safety, Tolerability, and Pharmacokinetics of Single- and Multiple-ascending Doses of ACT-777991 in Healthy Subjects

NCT ID: NCT04798209

Last Updated: 2022-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-29

Study Completion Date

2022-05-21

Brief Summary

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A study to examine the safety, tolerability, and pharmacokinetics of single- and multiple-ascending doses of ACT-777991 in healthy subjects.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Single-center, double-blind, randomized, placebo-controlled Phase 1 study
Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part A (single ascending dose) Dose A1

Single dose A1 of ACT-777991.

Group Type EXPERIMENTAL

ACT-777991 (SAD)

Intervention Type DRUG

ACT-777991 administered as hard capsules for oral use.

Placebo (SAD)

Intervention Type DRUG

ACT-777991 matching placebo administered as hard capsules for oral use.

Part A (single ascending dose arm) Dose A2

Single dose A2 of ACT-777991.

Group Type EXPERIMENTAL

ACT-777991 (SAD)

Intervention Type DRUG

ACT-777991 administered as hard capsules for oral use.

Placebo (SAD)

Intervention Type DRUG

ACT-777991 matching placebo administered as hard capsules for oral use.

Part A (single ascending dose arm) Dose A3

Single dose A3 of ACT-777991.

Group Type EXPERIMENTAL

ACT-777991 (SAD)

Intervention Type DRUG

ACT-777991 administered as hard capsules for oral use.

Placebo (SAD)

Intervention Type DRUG

ACT-777991 matching placebo administered as hard capsules for oral use.

Part A (single ascending dose arm) Dose A4

Single dose A4 of ACT-777991 under fasted and fed conditions, separated by at least 14 days.

Group Type EXPERIMENTAL

ACT-777991 (SAD)

Intervention Type DRUG

ACT-777991 administered as hard capsules for oral use.

Placebo (SAD)

Intervention Type DRUG

ACT-777991 matching placebo administered as hard capsules for oral use.

Part A (single ascending dose arm) Dose A5

Single dose A5 of ACT-777991.

Group Type EXPERIMENTAL

ACT-777991 (SAD)

Intervention Type DRUG

ACT-777991 administered as hard capsules for oral use.

Placebo (SAD)

Intervention Type DRUG

ACT-777991 matching placebo administered as hard capsules for oral use.

Part A (single ascending dose arm) Dose A6

Single dose A6 of ACT-777991.

Group Type EXPERIMENTAL

ACT-777991 (SAD)

Intervention Type DRUG

ACT-777991 administered as hard capsules for oral use.

Placebo (SAD)

Intervention Type DRUG

ACT-777991 matching placebo administered as hard capsules for oral use.

Part A (single ascending dose arm) Dose A7

Single dose A7 of ACT-777991.

Group Type EXPERIMENTAL

ACT-777991 (SAD)

Intervention Type DRUG

ACT-777991 administered as hard capsules for oral use.

Placebo (SAD)

Intervention Type DRUG

ACT-777991 matching placebo administered as hard capsules for oral use.

Part A (single ascending dose arm) Dose A8

Single dose A8 of ACT-777991.

Group Type EXPERIMENTAL

ACT-777991 (SAD)

Intervention Type DRUG

ACT-777991 administered as hard capsules for oral use.

Placebo (SAD)

Intervention Type DRUG

ACT-777991 matching placebo administered as hard capsules for oral use.

Part B (multiple ascending dose) Dose B1

Multiple doses B1 of ACT-777991.

Group Type EXPERIMENTAL

ACT-777991 (MAD)

Intervention Type DRUG

ACT-777991 administered as hard capsules for oral use, once daily.

Placebo (MAD)

Intervention Type DRUG

Matching placebo administered as hard capsules for oral use, once daily.

Part B (multiple ascending dose) Dose B2

Multiple doses B2 of ACT-777991.

Group Type EXPERIMENTAL

ACT-777991 (MAD)

Intervention Type DRUG

ACT-777991 administered as hard capsules for oral use, once daily.

Placebo (MAD)

Intervention Type DRUG

Matching placebo administered as hard capsules for oral use, once daily.

Part B (multiple ascending dose) Dose B3

Multiple doses B3 of ACT-777991.

Group Type EXPERIMENTAL

ACT-777991 (MAD)

Intervention Type DRUG

ACT-777991 administered as hard capsules for oral use, once daily.

Placebo (MAD)

Intervention Type DRUG

Matching placebo administered as hard capsules for oral use, once daily.

Part B (multiple ascending dose) Dose B4

Multiple doses B4 of ACT-777991.

Group Type EXPERIMENTAL

ACT-777991 (MAD)

Intervention Type DRUG

ACT-777991 administered as hard capsules for oral use, once daily.

Placebo (MAD)

Intervention Type DRUG

Matching placebo administered as hard capsules for oral use, once daily.

Part B (multiple ascending dose) Dose B5

Multiple doses B5 of ACT-777991.

Group Type EXPERIMENTAL

ACT-777991 (MAD)

Intervention Type DRUG

ACT-777991 administered as hard capsules for oral use, once daily.

Placebo (MAD)

Intervention Type DRUG

Matching placebo administered as hard capsules for oral use, once daily.

Part A (single ascending dose) Absolute Bioavailability

Single dose of ACT-777991 plus a single dose of 14C-ACT-777991. At one of the dose levels from A4 to A8.

Group Type EXPERIMENTAL

14C-ACT-777991 microtracer (SAD - Absolute Bioavailability)

Intervention Type DRUG

Single dose of 14C-ACT-777991 microtracer, administered intravenously.

Microtracer matching placebo (SAD - Absolute Bioavailability)

Intervention Type DRUG

Single dose of 14C-ACT-777991 microtracer matching placebo, administered intravenously.

Part B (multiple ascending dose) ADME

Multiple doses of ACT-777991 plus a single dose of 14C-ACT-777991. At one of the dose levels from B1 to B5.

Group Type EXPERIMENTAL

14C-ACT-777991 microtracer (MAD - ADME)

Intervention Type DRUG

Single dose of 14C-ACT-777991 microtracer, oral solution..

Microtracer matching placebo (MAD - ADME)

Intervention Type DRUG

Single dose of 14C-ACT-777991 microtracer matching placebo, oral solution.

Interventions

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ACT-777991 (SAD)

ACT-777991 administered as hard capsules for oral use.

Intervention Type DRUG

ACT-777991 (MAD)

ACT-777991 administered as hard capsules for oral use, once daily.

Intervention Type DRUG

Placebo (SAD)

ACT-777991 matching placebo administered as hard capsules for oral use.

Intervention Type DRUG

Placebo (MAD)

Matching placebo administered as hard capsules for oral use, once daily.

Intervention Type DRUG

14C-ACT-777991 microtracer (SAD - Absolute Bioavailability)

Single dose of 14C-ACT-777991 microtracer, administered intravenously.

Intervention Type DRUG

Microtracer matching placebo (SAD - Absolute Bioavailability)

Single dose of 14C-ACT-777991 microtracer matching placebo, administered intravenously.

Intervention Type DRUG

14C-ACT-777991 microtracer (MAD - ADME)

Single dose of 14C-ACT-777991 microtracer, oral solution..

Intervention Type DRUG

Microtracer matching placebo (MAD - ADME)

Single dose of 14C-ACT-777991 microtracer matching placebo, oral solution.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
* Healthy male (Part A and B) and female subjects (Part B) aged between 18 and 55 years (inclusive) at Screening.
* Healthy on the basis of medical history, physical examination, cardiovascular assessments, and clinical laboratory tests.
* Male subjects with a partner who might become pregnant must either be vasectomized or agree to practice adequate contraception from admission to the study site until 3 months after dosing, or the partner must consistently and correctly use a highly effective method of contraception.


* Women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1. They must consistently and correctly use a highly effective method of contraception with a failure rate of less than 1% per year, be sexually inactive, or have a vasectomized partner.
* Women of non-childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1.

Exclusion Criteria

* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
* History or clinical evidence of any disease and/or existence of any surgical or medical condition, which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment.


* Radiation exposure, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 milli sievert (mSv) in the last 12 months or 10 mSv in the last 5 years. Occupationally exposed workers, as defined in the relevant Ionising Radiation Regulations, must not participate in the study.
* Participation in any study involving administration of any Carbon-14 (14C) radiolabeled compound within the 12 months prior to Screening.


* Pregnant or lactating women.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Idorsia Pharmaceuticals Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Idorsia Pharmaceuticals Ltd.

Locations

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QPS Netherlands B.V.

Groningen, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2020-004464-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ID-089-101

Identifier Type: -

Identifier Source: org_study_id

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