NCT04608513

Brief Summary

A safety and tolerability study in healthy subjects including examination of how the body takes up, distributes, and gets rid of ACT-1014-6470

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Nov 2020

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 29, 2020

Completed
18 days until next milestone

Study Start

First participant enrolled

November 16, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2021

Completed
Last Updated

October 15, 2021

Status Verified

October 1, 2021

Enrollment Period

10 months

First QC Date

October 23, 2020

Last Update Submit

October 7, 2021

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Safety profile including incidence of treatment-emergent adverse events.

    Safety and tolerability assessments will be performed at predefined time points from Day 1 to Day 4 in Part A and Day 1 to Day 10 in Part B (total duration: max. 50 days).

Secondary Outcomes (9)

  • Part A - Single ascending dose (SAD): Area under the plasma concentration-time curve (AUC) from zero to time t of the last measured concentration above the limit of quantification (AUC0-t).

    Blood samples for the determination of the PK parameters will be collected at predefined time points from Day 1 to Day 4 (total duration: max. 4 days).

  • Part A - Single ascending dose (SAD): Area under the plasma concentration-time curve (AUC) from zero to infinity (AUC0-inf).

    Blood samples for the determination of the PK parameters will be collected at predefined time points from Day 1 to Day 4 (total duration: max. 4 days).

  • Part A - Single ascending dose (SAD): Maximum plasma concentration (Cmax).

    Blood samples for the determination of the PK parameters will be collected at predefined time points from Day 1 to Day 4 (total duration: max. 4 days).

  • Part A - Single ascending dose (SAD): Time to reach Cmax (tmax).

    Blood samples for the determination of the PK parameters will be collected at predefined time points from Day 1 to Day 4 (total duration: max. 4 days).

  • Part A - Single ascending dose (SAD): Terminal half-life (t½).

    Blood samples for the determination of the PK parameters will be collected at predefined time points from Day 1 to Day 4 (total duration: max. 4 days).

  • +4 more secondary outcomes

Study Arms (12)

ACT-1014-6470 single dose (dose level 1)

EXPERIMENTAL

Soft capsule for oral administration

Drug: ACT-1014-6470

Placebo single dose (dose level 1)

PLACEBO COMPARATOR

Soft capsule for oral administration

Drug: Placebo

ACT-1014-6470 single dose (dose level 2)

EXPERIMENTAL

Soft capsule for oral administration

Drug: ACT-1014-6470

Placebo single dose (dose level 2)

PLACEBO COMPARATOR

Soft capsule for oral administration

Drug: Placebo

ACT-1014-6470 multiple dose (dose level 1)

EXPERIMENTAL

Soft capsule for oral administration

Drug: ACT-1014-6470

Placebo multiple dose (dose level 1)

PLACEBO COMPARATOR

Soft capsule for oral administration

Drug: Placebo

ACT-1014-6470 multiple dose (dose level 2)

EXPERIMENTAL

Soft capsule for oral administration

Drug: ACT-1014-6470

Placebo multiple dose (dose level 2)

PLACEBO COMPARATOR

Soft capsule for oral administration

Drug: Placebo

ACT-1014-6470 multiple dose (dose level 3)

EXPERIMENTAL

Soft capsule for oral administration

Drug: ACT-1014-6470

Placebo multiple dose (dose level 3)

PLACEBO COMPARATOR

Soft capsule for oral administration

Drug: Placebo

ACT-1014-6470 multiple dose (dose level 4)

EXPERIMENTAL

Soft capsule for oral administration

Drug: ACT-1014-6470

Placebo multiple dose (dose level 4)

PLACEBO COMPARATOR

Soft capsule for oral administration

Drug: Placebo

Interventions

ACT-1014-6470DRUG

Soft capsules for oral administration

ACT-1014-6470 multiple dose (dose level 1)ACT-1014-6470 multiple dose (dose level 2)ACT-1014-6470 multiple dose (dose level 3)ACT-1014-6470 multiple dose (dose level 4)ACT-1014-6470 single dose (dose level 1)ACT-1014-6470 single dose (dose level 2)
PlaceboDRUG

Soft capsules for oral administration

Placebo multiple dose (dose level 1)Placebo multiple dose (dose level 2)Placebo multiple dose (dose level 3)Placebo multiple dose (dose level 4)Placebo single dose (dose level 1)Placebo single dose (dose level 2)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • General criteria
  • Signed informed consent prior to any study-mandated procedure.
  • Healthy male subjects (both study parts) and female subjects of nonchildbearing potential (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 that 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 (from Screening, during the entire study, and for at least 3 months after last study treatment intake) a highly effective method of contraception.
  • Criteria for Part B only:
  • 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:

  • Previous exposure to the study medication.
  • 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.
  • Relevant bacterial, viral, fungal, or protozoal infection that manifested within the last 6 weeks prior to Screening and/or ongoing relevant bacterial, viral, fungal, or protozoal infection, as judged by the investigator, and/or evidence of immune dysfunction based on laboratory tests at Screening.
  • Any signs or symptoms of active, ongoing infection judged to be clinically relevant by the investigator (special attention should be given to clinical signs and symptoms consistent with COVID-19, e.g., fever, dry cough, dyspnea, sore throat, or fatigue).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parexel International GmbH Klinikum Westend

Berlin, 14050, Germany

Location

MeSH Terms

Interventions

ACT-1014-6470

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Single-center, double-blind, randomized, placebo-controlled, single- and multiple-ascending dose
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2020

First Posted

October 29, 2020

Study Start

November 16, 2020

Primary Completion

September 20, 2021

Study Completion

September 20, 2021

Last Updated

October 15, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)