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A Phase 1 SAD and MAD Study of the Safety, Tolerability and PK of 7HP349 in Normal Healthy Male Subjects

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ClinicalTrials.gov Identifier: NCT04508179
Recruitment Status : Recruiting
First Posted : August 11, 2020
Last Update Posted : January 13, 2021
Sponsor:
Collaborator:
Frontage Clinical Services, Inc.
Information provided by (Responsible Party):
7 Hills Pharma, LLC

Brief Summary:
This study will evaluate the safety, tolerability and pharmacokinetics of 7HP349, an allosteric integrin activator, in healthy male subjects

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: 7HP349 Single Ascending Dose Drug: 7HP349 Multiple Ascending Dose Drug: Placebo Single Ascending Dose Drug: Placebo Multiple Ascending Dose Drug: 7HP349 Food Effect Phase 1

Detailed Description:

This first-in-human (FIH) study consists of a placebo-controlled, sequential, dose escalation study to determine the safety, tolerability and pharmacokinetics (PK) of 7HP349 following single and multiple oral dose administration to healthy male subjects, with a separate, open-label food effect cohort at the optimal pharmacokinetic dose (OPD). The study will be carried out in 3 parts.

Part A: This is a placebo-controlled, within-cohort randomized, double-blind, sequential, single ascending dose (SAD) escalation study to determine the safety, tolerability and PK of 7HP349 following administration of single oral doses in healthy male subjects, and to define the OPD of 7HP349.

Part B: This is a placebo-controlled, within-cohort randomized, double-blind, sequential, multiple ascending dose (MAD) escalation study to determine the safety, tolerability and PK of 7HP349 following up to 5 once daily oral doses in healthy male subjects.

Part C: This is a randomized, open label, two-treatment, two-period, crossover study to evaluate the effect of the fed or fasting prandial state on the single dose PK of 7HP349.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: This study consists of three parts, Part A, Part B and Part C, which will be undertaken sequentially. Part A is a SAD study to determine the safety, tolerability and PK of 7HP349 in healthy male subjects, and to define the OPD. Part B is a MAD study to determine the safety, tolerability and PK of 7HP349 following up to 5 once daily oral doses in healthy male subjects. Part C is a crossover study to evaluate the effect of the fed or fasting prandial state on the single dose PK of 7HP349.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Placebo-controlled, Within-Cohort Randomized, Double-blind, Single and Multiple Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of 7HP349 in Normal Healthy Male Subjects
Actual Study Start Date : October 28, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
Experimental: 7HP349 Capsules
Part A: 7HP349 Capsules (5 cohorts); Part B: 7HP349 Capsules (2 cohorts); Part C: 7HP349 Capsules (2-period cross-over)
Drug: 7HP349 Single Ascending Dose
Part A: 7HP349 Capsules, Single Ascending Dose (SAD)
Other Name: 7HP349 SAD

Drug: 7HP349 Multiple Ascending Dose
Part B: 7HP349 Capsules, Multiple Ascending Dose (MAD)
Other Name: 7HP349 MAD

Drug: 7HP349 Food Effect
Part C: 7HP349 Capsules, Food Effect
Other Name: 7HP349 FE

Placebo Comparator: Placebo Capsules
Part A: Placebo Capsules (5 cohorts); Part B: Placebo Capsules (2 cohorts)
Drug: Placebo Single Ascending Dose
Part A: Placebo Capsules, Single Ascending Dose (SAD)
Other Name: Placebo SAD

Drug: Placebo Multiple Ascending Dose
Part B: Placebo Capsules, Multiple Ascending Dose (MAD)
Other Name: Placebo MAD




Primary Outcome Measures :
  1. Safety and tolerability of 7HP349 in healthy male subjects as assessed by incidence of treatment-emergent adverse events according to CTCAE v5.0 criteria [ Time Frame: 17 days ]
    Safety assessments will include evaluation of incidence of treatment-emergent adverse events (AEs) according to CTCAE v5.0 criteria, including vital signs, resting electrocardiogram (ECG) parameters, standard hematology, chemistry, urinalysis and other tests


Secondary Outcome Measures :
  1. Pharmacokinetics of 7HP349 in healthy male subjects as assessed by maximum plasma concentration (Cmax) towards determination of the optimal pharmacokinetic dose (OPD) [ Time Frame: 17 days ]
    Determination of maximum plasma concentration (Cmax)

  2. Pharmacokinetics of 7HP349 in healthy male subjects as assessed by plasma exposure (AUClast and/or AUCinf) towards determination of the optimal pharmacokinetic dose (OPD) [ Time Frame: 17 days ]
    Determination of plasma exposure (AUClast and/or AUCinf)

  3. Pharmacokinetics of 7HP349 in healthy male subjects as assessed by exposure in urine towards determination of the optimal pharmacokinetic dose (OPD) [ Time Frame: 17 days ]
    Determination of exposure in urine

  4. Pharmacokinetics of 7HP349 in healthy male subjects as assessed by renal clearance (CLr) towards determination of the optimal pharmacokinetic dose (OPD) [ Time Frame: 17 days ]
    Determination of renal clearance (CLr)

  5. Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of maximum plasma concentration (Cmax) in fed individuals [ Time Frame: 28 days ]
    Fed prandial state, determination of maximum plasma concentration (Cmax)

  6. Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of maximum plasma exposure (AUClast and/or AUCinf) in fed individuals [ Time Frame: 28 days ]
    Fed prandial state, determination of plasma exposure (AUClast and/or AUCinf)

  7. Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of maximum plasma concentration (Cmax) in fasted individuals [ Time Frame: 28 days ]
    Fasted prandial state, determination of maximum plasma concentration (Cmax)

  8. Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of maximum plasma exposure (AUClast and/or AUCinf) in fasted individuals [ Time Frame: 28 days ]
    Fasted prandial state, determination of plasma exposure (AUClast and/or AUCinf)

  9. Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of the Geometric Mean Ratio (GMR) of the maximum plasma concentration (Cmax) in fed vs. fasted individuals [ Time Frame: 28 days ]
    Determination of Geometric Mean Ratio (GMR) of fed:fasted Cmax

  10. Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of the Geometric Mean Ratio (GMR) of the plasma exposure (AUClast and/or AUCinf) in fed vs. fasted individuals [ Time Frame: 28 days ]
    Determination of Geometric Mean Ratio (GMR) of fed:fasted AUClast and/or AUCinf



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males between the ages of 18 and 45 years, inclusive
  • Normal clinical chemistry, hepatic function, hematology, thyroid function
  • Body mass index (BMI) of 19 to 30 kg/m2 inclusive and body weight not less than 60 kg
  • Agree to refrain from consuming products containing grapefruit, pomelo, star fruit or Seville oranges for at least 7 days before the first dose of study drug until the final discharge evaluation
  • Positive immune status as defined in serum as measles, mumps, varicella-zoster viruses (VZR); Antibody Index (AI) ≥ 1.1, and positive Rubella: AI ≥ 1.0

Exclusion Criteria:

  • Clinically significant history of disorders, infections or drug hypersensitivity as determined by the Investigator
  • History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin
  • Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody
  • Current treatment or treatment within 30 days with another investigational medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04508179


Locations
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United States, New Jersey
Frontage Clinical Services Inc. Recruiting
Secaucus, New Jersey, United States, 07094
Contact: Michelle Pluviose, MS    201-416-7763    mpluviose@frontagelab.com   
Sponsors and Collaborators
7 Hills Pharma, LLC
Frontage Clinical Services, Inc.
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Responsible Party: 7 Hills Pharma, LLC
ClinicalTrials.gov Identifier: NCT04508179    
Other Study ID Numbers: 7HP-101a
First Posted: August 11, 2020    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No