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Completed

NCT Number: NCT03339752

A Study in Healthy Male Subjects to Investigate Whether Administration of ACT-541468 Can Affect the Fate in the Body (Amount and Time of Presence in the Blood) of Rosuvastatin

A study in healthy male subjects to investigate whether administration of ACT-541468 can affect the fate in the body (amount and time of presence in the blood) of rosuvastatin

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Key information

Conditions

Healthy Subjects

Age range

18 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Cepha s.r.o.

Pilsen, 32300, Czechia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent in the local language prior to any study mandated procedure;
  • Healthy male subjects aged 18 to 45 years (inclusive) at screening;
  • Body mass index of 18.0 to 28.0 kg/m2 (inclusive) at screening;
  • Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests.

Exclusion criteria

  • Known allergic reactions or hypersensitivity to ACT-541468, rosuvastatin, any drug of the same classes, or any of their excipients;
  • Any contraindication for rosuvastatin treatment;
  • History or clinical evidence of myopathy;
  • Asian or Indian-Asian ethnicity;
  • Known hypersensitivity or allergy to natural rubber latex;
  • Previous exposure to ACT-541468;
  • Treatment with rosuvastatin within 3 months prior to screening;
  • Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.

Treatment and study plan

Rosuvastatin

Drug

10 mg tablet

ACT-541468

Drug

25 mg hard capsule

Primary outcomes

  1. Effect of ACT-541468 at steady-state on Cmax of single-dose rosuvastatin

    Time frame: During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks.

    Effect of ACT-541468 at steady-state on Cmax of single-dose rosuvastatin

  2. Effect of ACT-541468 at steady-state on tmax of single-dose rosuvastatin

    Time frame: During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks.

    Effect of ACT-541468 at steady-state on tmax of single-dose rosuvastatin

  3. Effect of ACT-541468 at steady-state on AUC0-t of single-dose rosuvastatin

    Time frame: During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks.

    Effect of ACT-541468 at steady-state on AUC0-t of single-dose rosuvastatin

  4. Effect of ACT-541468 at steady-state on AUC0-∞ of single-dose rosuvastatin

    Time frame: During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks.

    Effect of ACT-541468 at steady-state on AUC0-∞ of single-dose rosuvastatin

  5. Effect of ACT-541468 at steady-state on t½ of single-dose rosuvastatin

    Time frame: During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks.

    Effect of ACT-541468 at steady-state on t½ of single-dose rosuvastatin

Secondary outcomes

  1. Trough concentration (Ctrough) of ACT-541468

    Time frame: During ACT-541468 administration (Treatment B1 and B2); i.e. for about 1 week

    Trough concentration (Ctrough) of ACT-541468

  2. Change in vital signs

    Time frame: From Screening to EOS (for a maximum of up to 5 weeks)

    Change from baseline to each time point of measurement during each treatment in vital signs (supine BP and pulse rate)

  3. Change in ECG variables

    Time frame: From Screening to EOS (for a maximum of up to 5 weeks)

    Change from baseline to each time point of measurement during each treatment in ECG variables

  4. Treatment-emergent (serious) adverse events

    Time frame: From Screening to EOS (for a maximum of up to 5 weeks)

    Treatment-emergent AEs and SAEs during each treatment

  5. Treatment-emergent ECG abnormalities

    Time frame: From Screening to EOS (for a maximum of up to 5 weeks)

    Treatment-emergent ECG abnormalities during each treatment

  6. Change in body weight

    Time frame: From Screening to EOS (for a maximum of up to 5 weeks)

    Change from baseline to each time point of measurement during each treatment in body weight

  7. Change in clinical laboratory tests

    Time frame: From Screening to EOS (for a maximum of up to 5 weeks)

    Change from baseline to each time point of measurement during each treatment in clinical laboratory tests

Sponsors and collaborators

Lead sponsor

Idorsia Pharmaceuticals Ltd.

Industry

Registry information

Official study title

A Single-center, Open-label, One-sequence, Two-treatment Study to Investigate the Effect of ACT-541468 at Steady State on the Pharmacokinetics of Rosuvastatin in Healthy Male Subjects

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 13, 2017
Registry last updated
Dec 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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