A Study to Examine the Safety, Tolerability, and Pharmacokinetics of Single- and Multiple-ascending Doses of ACT-1014-6470 in Healthy Subjects

Idorsia Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: ACT-1014-6470 (MAD); Drug: 14C-ACT-1014-6470 microtracer placebo; Drug: Placebo (MAD); Drug: Placebo (SAD); Drug: 14C-ACT-1014-6470 microtracer; Drug: ACT-1014-6470 (SAD)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04183686

ID-087-101

Details and patient eligibility

About

A study to examine the safety, tolerability, and pharmacokinetics of single- and multiple-ascending doses of ACT-1014-6470 in healthy subjects

Enrollment: 88 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

General 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.

Inclusion Criteria for Part B:

• 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 < 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.

General 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.

Exclusion Criteria for the ADME evaluation (Part A) only:

• Radiation exposure, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 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 14C radiolabeled compound within the 12 months prior to Screening.

Exclusion Criteria for Part B:

• Pregnant or lactating women.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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88 participants in 10 patient groups

Part A (SAD): Dose A1

Experimental group

Description:

Single dose A1 of ACT-1014-6470; soft capsule for oral use.

Treatment:

Drug: Placebo (SAD)

Drug: ACT-1014-6470 (SAD)

Part A (SAD): Dose A2

Experimental group

Description:

Single dose A2 of ACT-1014-6470; soft capsule for oral use.

Treatment:

Drug: Placebo (SAD)

Drug: ACT-1014-6470 (SAD)

Part A (SAD): Dose A3

Experimental group

Description:

Single dose A3 of ACT-1014-6470 under fasted and fed conditions, separated by at least 18 days; soft capsule for oral use.

Treatment:

Drug: Placebo (SAD)

Drug: ACT-1014-6470 (SAD)

Part A (SAD): Dose A4

Experimental group

Description:

Single dose A4 of ACT-1014-6470; soft capsule for oral use.

Treatment:

Drug: Placebo (SAD)

Drug: 14C-ACT-1014-6470 microtracer

Drug: ACT-1014-6470 (SAD)

Drug: 14C-ACT-1014-6470 microtracer placebo

Part A (SAD): Dose A5

Experimental group

Description:

Single dose A5 of ACT-1014-6470; soft capsule for oral use.

Treatment:

Drug: Placebo (SAD)

Drug: ACT-1014-6470 (SAD)

Part A (SAD): Dose A6

Experimental group

Description:

Single dose A6 of ACT-1014-6470; soft capsule for oral use.

Treatment:

Drug: Placebo (SAD)

Drug: ACT-1014-6470 (SAD)

Part B (MAD): Dose B1

Experimental group

Description:

Multiple doses B1 of ACT-1014-6470; soft capsules for oral use.

Treatment:

Drug: Placebo (MAD)

Drug: ACT-1014-6470 (MAD)

Part B (MAD): Dose B2

Experimental group

Description:

Multiple doses B2 of ACT-1014-6470; soft capsules for oral use.

Treatment:

Drug: Placebo (MAD)

Drug: ACT-1014-6470 (MAD)

Part B (MAD): Dose B3

Experimental group

Description:

Multiple doses B3 of ACT-1014-6470; soft capsules for oral use.

Treatment:

Drug: Placebo (MAD)

Drug: ACT-1014-6470 (MAD)

Part B (MAD): Dose B4

Experimental group

Description:

Multiple doses B4 of ACT-1014-6470; soft capsules for oral use.

Treatment:

Drug: Placebo (MAD)

Drug: ACT-1014-6470 (MAD)