Trials Sponsors Conditions Drugs Pricing

Conditions

FOP

Outcome Measures

Primary Outcomes (8)

Maximum (peak) plasma drug concentration
pre-dose (0 hour), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours post-drug administration.
Time to reach maximum (peak) plasma concentration following drug administration
pre-dose (0 hour), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours post-drug administration.
Area under the plasma concentration time curve from time zero to the last quantifiable time point, calculated by linear-log trapezoidal summation
pre-dose (0 hour), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours post-drug administration.
Area under the plasma concentration time curve from time zero to infinity, calculated by linear-log trapezoidal summation and extrapolated to infinity by addition of the last quantifiable plasma concentration divided by the elimination rate constant
pre-dose (0 hour), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours post-drug administration.
Terminal disposition rate constant/terminal rate constant, determined by linear regression of the terminal points of the log-linear plasma concentration-time curve
pre-dose (0 hour), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours post-drug administration.
Elimination half-life
pre-dose (0 hour), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours post-drug administration.
Apparent volume of distribution after non-intravenous (oral) administration
pre-dose (0 hour), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours post-drug administration.
Apparent total clearance of the drug from plasma after oral administration calculated by dose/ AUC(0-∞)
pre-dose (0 hour), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours post-drug administration.

Study Arms (2)

Japanese group

EXPERIMENTAL

The subjects will receive in Period 1 either the low-dose or high-dose first, and in Period 2 they will receive the alternate dose. There is a washout period between periods.

Drug: palovarotene low-doseDrug: palovarotene high-dose

non-Asian group

EXPERIMENTAL

The subjects will receive in Period 1 either the low-dose or high-dose first, and in Period 2 they will receive the alternate dose. There is a washout period between periods.

Drug: palovarotene low-doseDrug: palovarotene high-dose

Interventions

palovarotene low-doseDrug

oral capsules

Japanese groupnon-Asian group

palovarotene high-doseDrug

oral capsules

Japanese groupnon-Asian group

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

The subject had a body mass index (BMI) of 18 to 30 kg/m2 and a body weight of 50 kg or more. Body mass index was calculated as follows: weight (kg)/height2 (m2).
The subject had a resting (at least 5 minutes) sitting pulse of greater than 45 but less than 100 beats per minute (BPM) and systolic and diastolic blood pressure (BP) of less than 140/90 mmHg

Sponsors & Collaborators

Clementia Pharmaceuticals Inc.
Industrylead

MeSH Terms

Interventions

Palovarotene

Study Officials

Ipsen Medical Director
Ipsen
STUDY DIRECTOR

Enrollment

18 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

April 1, 2021

First Posted

April 2, 2021

Study Start

September 1, 2015

You may not qualify if:

The subject had a history or current evidence of a clinically significant or uncontrolled disease, including but not limited to: cardiovascular, hepatic, renal, hematological, neuropsychological, endocrine, gastrointestinal, reproductive, or pulmonary.
The subject was pregnant, nursing, or planned to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days following the subject's last study-related visit (for eligible subjects only, if applicable).
The subject had a medical condition that may have potentially been aggravated by a systemic retinoid such as isotretinoin or etretinate.
The subject had been exposed to synthetic oral retinoids in the past 30 days prior to the screening visit (signature of the informed consent).
The subject was currently using vitamin A or beta carotene, multivitamins containing vitamin A or beta carotene, or herbal preparations, fish oil, and was unable or unwilling to discontinue use of these products for the duration of the study.
The subject had a history or presence of silent infections, including positive tests for human immunodeficiency virus type 1 (HIV-1), HIV-2, hepatitis B virus (HBV), or hepatitis C virus (HCV).
The subject had any disease or condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
The subject had concurrent treatment with tetracycline due to the potential increased risk of pseudotumor cerebri.
The subject had a history of allergy or hypersensitivity to retinoids or lactose.
The subject had been exposed to any investigational drug within 30 days or six half-lives (whichever is greater) of the screening visit.
The subject had been treated with any known CYP450 3A4 inhibitors (eg, ketoconazole, gestodene, rifampin) within 30 days prior to the screening visit.
The subject had a history of alcohol and/or substance abuse.
The subject was considered to be vulnerable (eg, cognitively impaired, a person kept in detention).
Any reason that in the opinion of the Investigator would have led to the inability of the subject and/or family to comply with the protocol.

Study to Compare the Pharmacokinetics, Safety, and Tolerability Following Administration of Palovarotene in Healthy Japanese and Non-Asian Subjects

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (8)

Study Arms (2)

Japanese group

non-Asian group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (8)

Study Arms (2)

Japanese group

non-Asian group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record