NCT05164614已完成1 期
A Phase I Study to Evaluate the Pharmacokinetics of Parathyroid Hormone (1-34) Administered Orally Via RaniPill™ Capsule
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Evaluate Cmax of PTH administered via the RaniPill capsule
研究概览
简要总结
A prospective, single-center, open-label, phase I study evaluating the pharmacokinetics (PK) of human parathyroid hormone (1-34) ("PTH") administered via the RaniPill™ capsule ("RT-102").
详细描述
The RaniPill device is a capsule-like ingestible device, which injects a microneedle containing a micro tablet (payload/drug) into the intestinal wall. This is a single-center, prospective, open-label, feasibility study being conducted in two parts.
Part 1: Healthy women volunteers, 18-65 years of age, of any race, recruited from the general population and assigned to one of the following groups:
RT-102:
- RT-102 Group 1: 20 µg (N=15)
- RT-102 Group 2: 80 µg (N=15)
Subcutaneous (SC):
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participant understands and voluntarily signs the approved informed consent document prior to the performance of any study-specific procedures
- •Willing to comply with all study procedures and available for the entire duration of the study
- •Participant is ambulatory female between 18 to 65 years of age.
- •BMI between 19 to 32 kg/m
- •In good health, determined by no clinically significant findings from medical history, physical examination, laboratory tests, and vital signs.
- •Non-menstruating, non-pregnant or non-lactating women during study participation NOTE: Females who are of childbearing potential must have had a negative pregnancy test on day of screening. Contraception (double barrier contraception and be protected by a daily combination birth control pill containing estrogen and progestin or any other form of hormonal contraceptive if cannot use the contraceptive pill) should be used between Screening visit and 30 days after dosing if actively engaged in penile-vaginal intercourse.
- •Part 2: Healthy Women
- •Participant understands and voluntarily signs the approved informed consent document prior to the performance of any study-specific procedures
- •Willing to comply with all study procedures and available for the entire duration of the study
- •Participant is ambulatory female between 18 to 65 years of age.
- •BMI between 19 to 32 kg/m
- •In good health, determined by no clinically significant findings from medical history, physical examination, laboratory tests, and vital signs.
- •Non-menstruating, non-pregnant or non-lactating women during study participation NOTE: Females who are of childbearing potential must have had a negative pregnancy test on day of screening. A double barrier approach using highly effective methods of contraception (e.g., oral contraceptives containing combined estrogen and progesterone, a vaginal ring, injectable and implantable hormonal contraceptives, intrauterine hormone-releasing system [e.g., Mirena], progestogen-only hormonal contraception associated with inhibition of ovulation, nonhormonal intrauterine device, bilateral tubal occlusion) should be used between Screening visit and 30 days after dosing if actively engaged in penile-vaginal intercourse.
- •Part 2: Post-menopausal/surgically sterile
- •Participant understands and voluntarily signs the approved informed consent document prior to the performance of any study-specific procedures
- •Willing to comply with all study procedures and available for the entire duration of the study
- •Healthy ambulatory female post-menopausal for at least 1 year or surgically sterile with bilateral oophorectomy
- •BMI between 19 to 32 kg/m
- •In good health, determined by no clinically significant findings from medical history, physical examination, laboratory tests, and vital signs.
排除标准
- •Participants with known history of chronic constipation, gastroparesis / delayed gastric emptying, gastric or duodenal ulcers, dysphagia, dyspepsia, esophagitis, esophageal spasm, GERD, IBD, Crohn's disease, stomas, tumors, ischemic or ulcerative colitis
- •Participant has known history of intolerance of PTH (1-34)
- •Participant has known history of high levels of uric acid outside normal ranges
- •Participant has known history of osteoporosis or other bone disorders (such as Paget's disease)
- •Participant has known history of Cushing's disease, hypo- or hyper-parathyroidism or malabsorptive syndromes within the past year
- •Participant is taking calcium and/or vitamin D supplements within 7 days of treatment (including multi-vitamins containing calcium and/or vitamin D)
- •Participant has febrile illness within 30 days of the study procedures
- •Participant currently treated with parathyroid hormone, parathyroid hormone-related peptide-derived drugs, or bone anabolic steroids, including abaloparatide, teriparatide, or parathyroid hormone (1-84)
- •Participant currently treated with intravenous bisphosphonates for at least 1 month or oral bisphosphonates within the past year (12 months). Subjects who have received a short course of oral bisphosphonate therapy (3 months or less) may be enrolled if the treatment occurred 6 or more months prior to enrollment
- •Participants on a regimen of proton pump inhibitors (e.g. omeprazole) or histamine H2 receptor antagonists (e.g. ranitidine)
- •Participants with known bowel obstruction/stricture/fistula
- •Participants who have undergone gastrointestinal surgery (Roux-en-Y, Billroth II, Whipple, intestinal resection for any reason)
- •Participants who have undergone a recent (less than a month) barium X-ray procedure
- •Participants with known allergies or sensitivity to contrast media or barium sulfate
- •Participant with history of chronic disease that in the investigator's judgement may impact subject safety or study outcomes
- •Participants with congestive heart failure, renal failure
- •Presence of cardiac pacemaker or implanted electromedical device
- •Participant who is pregnant or lactating
- •Participant has received an investigational or marketed drug during a trial within the past 1 month or 5 half-lives of the investigational drug, whichever is longer
- •Participant received COVID-19 vaccine within 7 days of dosing
- •Participant is unlikely, in the investigator's judgment, to be able to complete participation in the study as required per study plan
- •Any other history which, in the investigator's judgment, makes the participant ineligible or places the participant at risk
- •Part 2: Healthy Women
- •Participants with known history of chronic constipation, gastroparesis / delayed gastric emptying, gastric or duodenal ulcers, dysphagia, dyspepsia, esophagitis, esophageal spasm, GERD, IBD, Crohn's disease, stomas, tumors, ischemic or ulcerative colitis
- •Participant has known history of intolerance of PTH (1-34)
- •Participant has known history of high levels of uric acid outside normal ranges
- •Participant has known history of osteoporosis or other bone disorders (such as Paget's disease)
- •Participant has known history of Cushing's disease, hypo- or hyper-parathyroidism or malabsorptive syndromes within the past year
- •Participant is taking calcium and/or vitamin D supplements within 7 days of treatment (including multi-vitamins containing calcium and/or vitamin D)
- •Participant has febrile illness within 30 days of the study procedures
- •Participant currently treated with parathyroid hormone, parathyroid hormone-related peptide-derived drugs, or bone anabolic steroids, including abaloparatide, teriparatide, or parathyroid hormone (1-84)
- •Participant currently treated with intravenous bisphosphonates for at least 1 month or oral bisphosphonates within the past year (12 months). Subjects who have received a short course of oral bisphosphonate therapy (3 months or less) may be enrolled if the treatment occurred 6 or more months prior to enrollment
- •Participants on a higher than the lowest approved therapeutic dose regimen of proton pump inhibitors (see Section 8.3.9 for details)
- •Participants on a H2 receptor antagonists (e.g. ranitidine)
- •Participants with known bowel obstruction/stricture/fistula
- •Participants who have undergone gastrointestinal surgery (Roux-en-Y, Billroth II, Whipple, intestinal resection for any reason)
- •Participants who have undergone a recent (less than a month) barium X-ray procedure
- •Participants with known allergies or sensitivity to contrast media or barium sulfate
- •Participant with history of chronic disease that in the investigator's judgement may impact subject safety or study outcomes
- •Participants with congestive heart failure, renal failure
- •Presence of cardiac pacemaker or implanted electromedical device
- •Participant who is pregnant or lactating
- •Participant has received an investigational or marketed drug during a trial within the past 1 month or 5 half-lives of the investigational drug, whichever is longer
- •Participant received COVID-19 vaccine within 7 days of dosing
- •Participant is unlikely, in the investigator's judgment, to be able to complete participation in the study as required per study plan
- •Any other history which, in the investigator's judgment, makes the participant ineligible or places the participant at risk
- •Part 2: Post-menopausal/surgically sterile
- •Participants with known history of chronic constipation, gastroparesis / delayed gastric emptying, gastric or duodenal ulcers, dysphagia, dyspepsia, esophagitis, esophageal spasm, GERD, IBD, Crohn's disease, stomas, tumors, ischemic or ulcerative colitis
- •Participant has known history of intolerance of PTH (1-34)
- •Participant has known history of high levels of uric acid outside normal ranges
- 另有 19 项未显示
研究组 & 干预措施
RT-102 Group 1
Experimental
In 15 subjects, a RaniPill capsule containing 20 µg of PTH will be administered and serial blood samples will be collected for PK analysis.
干预措施: RT-102 (20 μg) (Combination Product)
RT-102 Group 2
Experimental
In 15 subjects, a RaniPill capsule containing 80 µg of PTH will be administered and serial blood samples will be collected for PK analysis.
干预措施: RT-102 (80 μg) (Combination Product)
SC Group
Active Comparator
In 10 subjects, 20 µg of Forteo will be administered subcutaneously and serial blood samples will be collected for PK analysis.
干预措施: Forteo (Drug)
Part 2; Group 1
Experimental
In up to 7 subjects, once-a-day repeat dosing with RT-102 (20 mcg) for 7 days in healthy post-menopausal or surgically sterile with bilateral oophorectomy women.
干预措施: RT-102 (20 μg) (Combination Product)
Part 2; Group 2
Experimental
In up to 12 subjects, once-a-day repeat dosing with RT-102 (20 mcg) for 7 days in healthy women.
干预措施: RT-102 (20 μg) (Combination Product)
结局指标
主要结局
Evaluate Cmax of PTH administered via the RaniPill capsule
时间窗: Within 24 hours after ingestion of the device
To obtain PK profiles of single doses of PTH given via RaniPill™ capsule in healthy participants with doses of 20 and 80 μg. Cmax of PTH will be calculated from the PK profiles.
Evaluate Tmax of PTH administered via the RaniPill capsule
时间窗: Within 24 hours after ingestion of the device
To obtain PK profiles of single doses of PTH given via RaniPill™ capsule in healthy participants with doses of 20 and 80 μg. Tmax of PTH will be calculated from the PK profiles.
Evaluate AUC of PTH administered via the RaniPill capsule
时间窗: Within 24 hours after ingestion of the device
To obtain PK profiles of single doses of PTH given via RaniPill™ capsule in healthy participants with doses of 20 and 80 μg. Absorption (AUC) of PTH will be calculated from the PK profiles.
次要结局
- Safety and tolerability of RT-102(Within 24 hours after ingestion of the device)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Study to Assess Pharmacokinetics, Pharmacodynamics and Safety of Tiprogrel in Healthy SubjectsIschemic StrokeAcute Coronary SyndromeNCT06584812Tianjin Institute of Pharmaceutical Research Co., Ltd14
已完成
1 期
Pharmacokinetic Study of AR882 in Subjects With Various Degrees of Renal ImpairmentRenal ImpairmentNCT04646889Arthrosi Therapeutics46
已完成
1 期
Study of Felzartamab in Healthy Adult SubjectsHealthyNCT06285201TJ Biopharma Co., Ltd.60
招募中
1 期
A First-in-Human Study of a Controlled Release Formulation of Lanreotide acetate in healthy male volunteersNeuroendocrine TumoursMetabolic and Endocrine - Other endocrine disordersCancer - Neuroendocrine tumour (NET)AcromegalyACTRN12620001261909Ascil Australia Pty LTD16
已完成
1 期
A First-in-Human Study of a new Controlled Release Formulation of Octreotide acetate in healthy male volunteersNeuroendocrine TumoursMetabolic and Endocrine - Other endocrine disordersCancer - Neuroendocrine tumour (NET)AcromegalyACTRN12620000108910Ascil Australia Pty Ltd8