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

NCT04183686 | Completed Phase 1

• 1 other identifier: ID-087-101
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• All cohorts: Area under the plasma concentration-time curve (AUC) from zero to infinity (AUC0-inf)

  Blood samples for determination of PK parameters will be collected at predefined time points from Day 1 to Day 4 of Part A (SAD, Day 1 to Day 8 for ADME cohort A4) and from Day 1 to Day X+3 of Part B (MAD, with Day X = day of last study treatment administration).

  Total duration of assessments: up to 3 weeks.

Other Outcomes (10)

• All cohorts: Maximum plasma concentration (Cmax).

  Total duration of assessments: up to 3 weeks.

• All cohorts: Time to reach Cmax (tmax).

  Total duration of assessments: up to 3 weeks.

• All cohorts: t½.

  Total duration of assessments: up to 3 weeks.

Study Arms (10)

Part A (SAD): Dose A1

EXPERIMENTAL

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

Drug: ACT-1014-6470 (SAD); Drug: Placebo (SAD)

Part A (SAD): Dose A2

EXPERIMENTAL

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

Drug: ACT-1014-6470 (SAD); Drug: Placebo (SAD)

Part A (SAD): Dose A3

EXPERIMENTAL

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

Drug: ACT-1014-6470 (SAD); Drug: Placebo (SAD)

Part A (SAD): Dose A4

EXPERIMENTAL

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

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

Part A (SAD): Dose A5

EXPERIMENTAL

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

Drug: ACT-1014-6470 (SAD); Drug: Placebo (SAD)

Part A (SAD): Dose A6

EXPERIMENTAL

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

Drug: ACT-1014-6470 (SAD); Drug: Placebo (SAD)

Part B (MAD): Dose B1

EXPERIMENTAL

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

Drug: ACT-1014-6470 (MAD); Drug: Placebo (MAD)

Part B (MAD): Dose B2

EXPERIMENTAL

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

Drug: ACT-1014-6470 (MAD); Drug: Placebo (MAD)

Part B (MAD): Dose B3

EXPERIMENTAL

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

Drug: ACT-1014-6470 (MAD); Drug: Placebo (MAD)

Part B (MAD): Dose B4

EXPERIMENTAL

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

Drug: ACT-1014-6470 (MAD); Drug: Placebo (MAD)

Interventions

ACT-1014-6470 (SAD) DRUG

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

Part A (SAD): Dose A1; Part A (SAD): Dose A2; Part A (SAD): Dose A3; Part A (SAD): Dose A4; Part A (SAD): Dose A5; Part A (SAD): Dose A6

ACT-1014-6470 (MAD) DRUG

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

Part B (MAD): Dose B1; Part B (MAD): Dose B2; Part B (MAD): Dose B3; Part B (MAD): Dose B4

Placebo (SAD) DRUG

Single dose of matching placebo; soft capsules for oral use.

Part A (SAD): Dose A1; Part A (SAD): Dose A2; Part A (SAD): Dose A3; Part A (SAD): Dose A4; Part A (SAD): Dose A5; Part A (SAD): Dose A6

Placebo (MAD) DRUG

Multiple doses of matching placebo; soft capsules for oral use.

Part B (MAD): Dose B1; Part B (MAD): Dose B2; Part B (MAD): Dose B3; Part B (MAD): Dose B4

14C-ACT-1014-6470 microtracer DRUG

Single dose of 14C-ACT-1014-6470 microtracer; soft capsules for oral use.

Part A (SAD): Dose A4

14C-ACT-1014-6470 microtracer placebo DRUG

Single dose of matching placebo; soft capsules for oral use.

Part A (SAD): Dose A4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 \< 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.

You may not qualify if:

• 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 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.
• \- Pregnant or lactating women.

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead

Study Sites (1)

PRA Health Sciences

Groningen, 9728 NZ, Netherlands

Location

MeSH Terms

Interventions

ACT-1014-6470; Sagittal Abdominal Diameter; mycophenolic adenine dinucleotide

Intervention Hierarchy (Ancestors)

Body Size; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Anthropometry; Investigative Techniques; Physiological Phenomena

Study Officials

• Clinical Trials

  Idorsia Pharmaceuticals Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-center, double-blind, randomized, placebo-controlled Phase 1 study

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: December 3, 2019
• Study Start: November 25, 2019
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: August 12, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)