Main objectivesTo evaluate the safety and tolerability of single- and multiple-ascending dose (SAD and MAD) administration of ACT-1014-6470 in healthy subjects.To investigate the pharmacokinetics (PK) of SAD and MAD administration of ACT-1014-6470…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
inflammatory diseases
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
PART A (SAD)
All cohorts under fed conditions
- Area under the plasma concentration-time curve (AUC) from zero to infinity
(AUC0-inf)
Secondary outcome
All cohorts under fed conditions
- Maximum plasma concentration (Cmax).
- Time to reach Cmax (tmax).
- t*.
Food effect evaluation only
- AUC0-inf under fasted conditions.
- Cmax under fasted conditions.
- tmax under fasted conditions.
- t* under fasted conditions.
PART B (MAD)
- AUC during a dosing interval (AUCtau) following the first and the last dose.
Safety
- Treatment-emergent adverse events (AEs) from the start of the study treatment
administration up to End-of-Study (EOS) or End-of-Period (EOP).
- Treatment-emergent serious AEs from the start of the study treatment
administration up to EOS or EOP.
Background summary
ACT-1014-6470 has not been administered to humans before. It has been
previously tested in the laboratory and on animals.
Study objective
Main objectives
To evaluate the safety and tolerability of single- and multiple-ascending dose
(SAD and MAD) administration of ACT-1014-6470 in healthy subjects.
To investigate the pharmacokinetics (PK) of SAD and MAD administration of
ACT-1014-6470 in healthy subjects.
Other objectives
To investigate the effect of food on the PK of ACT-1014-6470 after single-dose
administration in healthy male subjects.
To investigate the absorption, distribution, metabolism, and excretion (ADME)
characteristics of ACT-1014-6470 after a single oral administration of a
14C-radiolabeled ACT-1014-6470 microtracer in healthy male subjects.
Study design
Part A:
Cohorts A1, A2, A4, A5, A6: single dose
Cohort A3: 2 doses separated by at least 18 days
Part B: The treatment duration will not exceed 2 weeks.
Intervention
ACT-1014-6470 or placebo will be given once (multiple administrations in part
B) in the morning as oral capsule(s). In Group A4, ACT-1014-6470 (or placebo)
and 14C-ACT-1014-6470 (or placebo) will be given at the same time.
Study burden and risks
As ACT-1014-6470 will be administered to humans for the first time in this
study, side effects of ACT-1014-6470 in humans have
not been reported to date. However, ACT-1014-6470 has been studied extensively
in the laboratory and in animals.
Hegenheimermattweg 91
Allschwil 4123
CH
Hegenheimermattweg 91
Allschwil 4123
CH
Listed location countries
Age
Inclusion criteria
General 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.
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.
Exclusion criteria
General criteria
- Pregnant or lactating women.
- 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 (appendectomy and herniotomy allowed, cholecystectomy not
allowed).
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-003347-30-NL |
| CCMO | NL71553.056.19 |